As Life Science professionals with niche skills sets our clients are provided with an innovative, network based, qualitative service that produces results on hard to fill roles. The professionals we engage with are provided with invaluable technical and cultural insight into client companies ensuring they are sufficiently prepared to successfully engage in hiring processes. Our technical expertise across numerous verticals within the sector further enables us to interact on a meaningful basis with key decision makers so that we fully understand strategic technical and cultural fits.


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RECRUITMENT

CLIENT

Aphex’s industry experienced resourcing professionals have hands on experience working within Validation, Laboratories, Supply Chain, Procurement, Automation functions within the Life Sciences sector. Our professional qualification and verification approach ensures clients receive the most qualified professional. Contact us to manage your resourcing requirements.

PROFESSIONALS

Our value add is simple, you will be engaging with professionals that have proven and current experience of the Life Sciences industry with strong insights to client companies. This ensures that ambitious professionals are briefed and prepared accordingly throughout the rigours of the interview process, thus enhancing the probability of securing their next position.

PROFESSIONALS

Our value add is simple, you will be engaging with professionals that have proven and current experience of the Life Sciences industry with strong insights to client companies. This ensures that ambitious professionals are briefed and prepared accordingly throughout the rigours of the interview process, thus enhancing the probability of securing their next position.

AVAILABLE VACANCIES

2020-325 – QC & Commercial Stability Data Reviewer – Waterford City

Purpose:

To support Product Development and Commercial Supply by ensuring all components, raw materials, finished products and Stability are tested in accordance with cGxP.

Responsibilities:

  • To review raw data from testing of components/raw materials/finished products and stability in a timely & efficient manner.
  • To manage and control all raw data presented for review and file once completed.
  • To complete required release documentation including commercial stability summary sheets.
  • Trending of finished product and API testing.
  • Complete investigations in a timely and efficient manner where applicable.
  • Identify and action recommendations for improvements.
  • Implement 5S and Lean lab initiatives.
  • To support all other on-going laboratory functions & requirements.
  • To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • To perform additional team tasks as agreed to support effective running of the Business.
  • To assist in the preparation for customer/ regulatory inspections.
  • Health & Safety;
    • Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs.
    • Report any defects.
    • If unsure about safety requirements – ask.

 

Minimum Qualifications and Experience:

  • Qualified to a minimum of degree level.
  • At least two years’ experience working in a related technical environment.
  • Analytical Test Methods – Creation and Review.
  • Operation of HPLC.
  • Operation of GC, FT/IR.
  • Computer Skills/Excel etc.

 

 

2020-323 – QC & Stability Chemist – Waterford City

Purpose:

To support QC and Stability by ensuring all raw materials, packaging, finished products and Stability samples are analysed in accordance with cGxP.

Responsibilities:

  • To test and complete write up of QC raw material, packaging, finished product and stability samples in a timely & efficient manner.
  • To support all other on-going laboratory functions & requirements.
  • To prepare and review stability summary sheets where required.
  • To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • Check own work and that of others for accuracy.
  • To assist in the preparation for internal / customer/ regulatory inspections.
  • Involved in internal investigations e.g. Out of Specifications, Incidents & Deviation investigations etc.
  • Draft, review or revise documentation within the company documentation management system.
  • Report any Deviations/Out of Specifications to Senior Chemist and complete in a timely manner.
  • Health & Safety;
    • Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs.
    • Report any defects.

 

Minimum Qualifications and Experience:

  • Qualified to a minimum of honours degree level in Analytical Chemistry, Pharmaceutical science or related discipline.
  • At least two years’ experience working in a related technical environment is preferable but not essential.
  • Proficient in the use of HPLC & associated problem solving.
  • Proficient with Dissolution testing.
  • Strong analytical ability.
  • Quality Orientation.
  • Knowledge & proficiency of Microsoft products including, Excel, Word & Powerpoint.
  • Adaptability – maintain effectiveness in varying environments and with different tasks, responsibilities and people.
  • Broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions.
  • Analysis – secure relevant information and identify key issues and relationships from a base of information; relate and compare data from different sources, identifying cause-effect relationships.
  • Working effectively with team or those outside the formal line of authority to accomplish organisational goals; taking actions that respect the needs and contributions of others, subordinating own objectives to the objectives of the organisation.
  • Making efforts to listen and understand the customer (both internal and external); anticipating and providing solutions to customers needs; giving high priority to customer satisfaction.
  • Safety Awareness.

 

 

10447631 – Process Engineer - Athlone

Purpose:

The NPI Engineer is required to work with the Manufacturing Engineering Team on site in Athlone between the Fill Finish and Biologics facility under the direction of the Manufacturing Engineer in the area. The chosen candidate will be required to be self-directed with the ability to lead/work through projects assigned. The candidate will also be required to support other team members to improve yields, productivity and ensure production targets are met. They will have assigned responsibilities for ensuring all manufacturing requirements are met from a process equipment perspective for New Product Introductions to existing Aseptic Filling Equipment. In addition, they will be involved in ongoing and new continuous improvement projects in both the Fill Finish & Biologics facilities. This is a technical role requiring problem solving through data analysis using scientific methods focusing on process capability. The role will require the candidate to work closely with other departments such as Manufacturing, Utilities and Quality Assurance. This role will report overall into the Senior Manufacturing Engineering Manager and will offer scope for both personal and career development.

Responsibilities:

  • Leading/involvement in process improvement projects or New Product Introduction projects as directed.
  • Coordinate with other departments to develop the Engineering Strategy for new products introduced.
  • Manage integration of NPIs according to project lifecycles.
  • Provide engineering support for all activities in new product introductions to existing Aseptic Manufacturing Equipment.
  • Prepare project timelines & identify all resource requirements and evaluate financials for Manufacturing Engineering.
  • Practical problem solving and root case analysis.
  • Process parameter monitoring and control, yield analysis.
  • Follow through on actions logs, project milestones and presentations.
  • Look for new innovative technologies Build a deep understanding of process variables.
  • Daily, weekly & monthly reporting of product and process metrics.
  • Work with quality management systems, process change management, ISO, FMEA, risk assessment, standard work documents.

 

Minimum Qualifications and Experience:

  • Appropriate Engineering qualification. Ideally Chemical, Mechanical, Manufacturing or Material Engineering degree, NFQ Level 8 or higher.
  • Minimum of 5 years’ experience.
  • Knowledge of Six Sigma and lean systems is an advantage.
  • IT literacy will ideally include SQL databases and Minitab.
  • Experience in pharmaceutical processes is an advantage, particularly with Aseptic Filling (RABs or Isolator technologies.)
  • The candidate should be able to examine data to grasp issues, draw conclusions, and solve problems.
  • Ability to make informed and timely decisions that consider the facts, goals, constraints, and risks associated.
  • A team player with a can do, pro-active attitude and a passion for improvement.

 

 

11386 – Drafter - Dublin

Responsibilities:

  • Manage and co-ordinate the day to day project draughting and documentation requirements.
  • Manage, modify and update all models (3D) and drawings, ensuring they meet the company standards.
  • Ensure all drawings are stored correctly in electronic format.
  • Manage the checking/approvals of all drawings issued by department.
  • Maintaining drawing register.
  • Collecting drawing from various vendors and storing in an efficient manner.
  • Developing and updating document and drawing templates & layouts.
  • Production of parts lists for any drawing.
  • Supporting Standard Operating Procedures (SOPs) Work Instructions (WI’s.)
  • Liaising with various departments.
  • Ensure compliance with all regulatory GMP, Safety and Environmental requirements.
  • Input data management, including vendor information, surveys and specialist recommendations.
  • Other administration duties as required.

 

Minimum Qualifications and Experience:

  • Level 7 Engineering Qualification or equivalent industry experience.
  • Self-motivated and excellent organisational skills.
  • Engineering Documentation Management & drafting experience.
  • Excellent verbal and written communication skills.
  • Ability to work independently and as part of a team in a cross functional collaborative environment.
  • High level of attention to detail.
  • Competent and a good working knowledge of AutoCAD and/or similar packages for the production of drawings.
  • Proficient in Microsoft Office Suite (word/excel.)

 

 

11385 – Technical Specialist – Cork

Purpose:

This position will provide technical support to the Vaccines IPT to support the technology transfer and scale-up of new processes for Vaccines IPT manufacture meeting the company’s manufacturing priorities of: Compliance, Supply, HPO, Strategy and Profit Plan. The Technical Specialist will be required to collaborate and facilitate running of activities (e.g. scale-up, PPQ batch manufacture, and license submissions) in the Vaccines IPT value stream for Technology Transfer of processes to ensure the effective and efficient on-time delivery of these activities to Vaccines IPT. This requires the delivery of technical excellence to deliver components of a stable process, supported by a flexible, collaborative, multi-skilled teamwork environment.

Responsibilities:

  • Ensure the highest Quality, Compliance and Safety standards primarily with Technology Transfer but relating to all activities.
  • Work within a team to enable the team’s performance within the Vaccine Technology Transfer group in the Technical Operations Dept.
  • Responsible for the technical transfer and scale–up of a new process into Vaccines IPT.
  • Input into Technical planning and decisions for the Vaccines IPT, to ensure supply of high quality product through tactical planning and execution of production schedules.
  • Technical Review, ownership of and approval of Global Change management records as required.
  • Recommend technical approaches in line with global and local standards.
  • Benchmark and remain current with development of new technologies in the vaccine and biopharmaceutical processing field of expertise and seek to deploy process improvements through innovation and utilization of these technological advances.
  • Contribute for driving a culture of Continuous Improvement by deploying company Six Sigma tools and MPS within the IPT on projects such as: problem solving, reducing cycle time, Lean principles within the new processes.
  • Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
  • Participate and comply with the company Quality Management System (QMS) requirements, including ownership, as relevant.
  • Responsible for supporting a culture of Continuous Improvement by championing company Six Sigma tools within Technology Transfer for Vaccines IPT.

 

Minimum Qualifications and Experience:

  • Degree or Masters in a Science or Engineering discipline (preferably Biotechnology).
  • >3 years’ experience in biopharmaceutical/vaccines environment.
  • Trackwise/ SAP experience would be an advantage.
  • Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations. Experience of involvement in a technical project and advantage.
  • Knowledge of Regulations and applicable standards for Quality, Safety, Regulatory within the biopharmaceutical/vaccine area.
  • Preference for Lean Six Sigma qualification or experience of application of Lean principles.
  • Project management qualification such as, Project Management Professional is desirable.
  • Evidence of Continuous Professional Development.
  • Demonstrated knowledge in more than one pharmaceutical or Biopharmaceutical manufacturing operation (e.g. manufacturing, technology, validation, engineering, quality.)
  • Demonstrated ability in holding project team members responsible for results and being decisive about non-performers.
  • Demonstrated ability to realize improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
  • Demonstrated high level of problem solving and facilitation skills.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
  • Experience in an FDA / HPRA Regulated production environment.

 

11384 – Project Coordinator - Carlow

Purpose:

The Project Management Office (PMO) is in the process of preparing and enhancing current team to define, coordinate and manage the execution of our new facility start up operational readiness activities. With your help we will ensure success by clearly defining and tracking the activities and/or steps required to meet our Start Up and Manufacturing milestone dates. In this role, you will work with and coordinate multiple workstream deliverables to ensure our startup strategy is ready to be used and deployed during and post facility and equipment OQ right through to commercial manufacture. The PMO Program Coordinator will be responsible for driving the Operational Readiness of the site including New Production, Utilities and Warehousing. The Program Co-ordinator will report directly to the Project Management Office Manager.

Responsibilities:

  • Develop and drive the operational readiness planning for the site from OQ phase to filing.
  • Work with the construction, C+Q and Operational Readiness workstream teams on schedule integration, identification of threats to the Program and mitigations identification.
  • Maintains a thorough knowledge of project activities, short and long-term business priorities and objectives through regular communication with other functions.
  • Provide status updates on a regular basis to functional directors and project leadership on Operational readiness workstream performance.
  • Implementation of program risk management process to identify Risks and Opportunities related to activities – work with Area Owners and SME’s to develop contingency, remediation, modification or replacement activities.
  • Oversight and control of budget for activities post OQ, including resources, materials and other expense requirements.
  • Participate in, contribute and influence, the development of project schedules, identifying Key Deliverables to use in the planning function for the program.
  • Collaborate with all the site functional areas and other company support teams.
  • Build the process, toolkits /checklists, and schedule required by the team to actively carryout a successful startup of the facility.
  • Drive and develop core planning meetings, with the necessary agenda, input and outputs. Leading through a visual, metric driven approach with the teams.
  • Liaise with various company internal and external stakeholders to develop plans with a medium to long-term forward view and associated daily delivery plans.
  • Collaborate with global planners and site leadership to set long term Program execution plan.
  • Drive visible performance management, use KPI’s to track progress, monitoring actual performance versus plan promoting awareness to drive improvement. Identify areas of opportunity and prepare specific action plans.
  • Develop, model and implement strategies to improve scheduling capability and adherence and integration with other project phases.
  • Work with Project Schedulers (Pre and Post OQ) to coordinate the integration of CQV and operational readiness project schedules via Primavera P6 and MS Excel.
  • Develop critical path analysis and scenario production for time reduction within critical path.
  • Report of project progress, schedule opportunities and mitigations as required to management.

 

Minimum Qualifications and Experience:

  • Bachelors in Project Management preferred however will also consider applicants who have a Science or Engineering qualification.
  • Carried out similar role ideally within the pharmaceutical industry.
  • Expertise in Project and Program Execution.
  • Should be proficient with MS WORD/PowerPoint/Visio/Microsoft Project to create documents and presentations. Knowledge of Primavera P6 preferred.
  • Exceptional communication/interpersonal skills and ability to communicate to multiple levels within company.
  • Solid collaborative skills, to be able to work in a diverse organisation.
  • Strong networking skills within peer and other working groups.
  • Readiness to contribute to the creation and development of our new site culture.
  • Ability to manage broad range of stakeholders.

 

10585 – Energy Engineer - Cork

Purpose:

The role of the Energy Engineer is to support the site Energy function on site on behalf of the Engineering Department. The successful candidate will be responsible for ensuring there is a strong safety culture and performance in the management energy on site.

Responsibilities:

  • Project management and support of energy project and initiatives on site.
  • Be proactive in identifying energy improvement initiative and cost savings.
  • Establish and support site department energy teams and champions to ensure energy is a core part of people roles and responsibilities.
  • Support the energy monitoring & metering project and act as SPOC for future projects with an energy focus.
  • Ensure site compliance to ISO 50001.
  • Set up new Fire and safety equipment on maintenance system and implement maintenance routines to ensure high maintenance levels for new building start-ups.
  • Ensure Project Design meets Energy Efficient Design (EED) for New / Upgrades builds to Site, National and company Global Building Standards.
  • Agree Energy Reduction KPI’s with Site IPT’s and ensure compliance to same.
  • Support the site to hit annual energy reduction targets set out by corporate requirements.
  • Conduct site energy awareness events.
  • Carry out inspections and audits of site energy compliance and compliance to ISO 50001 management system.
  • Support and manage the implementation of the site 10-year energy strategy.
  • Analyze the requirement, need and feasibility for renewable energy for the site.
  • Investigate the opportunity of using new technology to manage and reduce energy consumption on site.
  • Use Lean principles across all technical aspects of the process, by deploying company Six Sigma tools.
  • Responsible for driving a culture of Compliance and delivery on time.

 

Minimum Qualifications and Experience:

  • Degree or 3rd Level Qualification (Engineering.)
  • Desirable to have qualification Energy Management.
  • 3+ Yrs. working in a similar role.
  • Desirable evidence of Continuous Professional Development.
  • Must have a thorough understanding and application of engineering principles, concepts, industry practices and standards.
  • Must have meticulous planning and strong communication skills.
  • Ability to work on own initiative to resolve issues.
  • Demonstrated high level of problem-solving skills.
  • Advanced PC skills such as Excel, Word, PowerPoint, MS Project or Primavera (SAP, MIDAS, TRACKWISE and SharePoint use experience also an advantage.)
  • High level of knowledge of Safety, Quality and Environmental requirements.
  • Excellent verbal and written communication skills/presentation skills.
  • Ability to plan, prioritise and effectively manage time, meet deadlines and produce quality deliverables.
  • Proven knowledge, appreciation and experience of working in strongly regulated GMP environment.
  • Understands the typical project life cycle from concept through to qualification and has proven experience in this area.
  • Demonstrated successes in a team environment, such as project teams.

 

10424 – Drafter - Cork

Purpose:

This role will be to provide support to the existing Cork Drawing Office and Engineering Project teams in the preparation of CAD drawings. As an integral part of a design team you will be responsible for developing new drawings, amending existing drawings to reflect as built conditions in the field. Candidates should be motivated and enthusiastic, have the ability to work on their own initiative and be able to meet deadlines and liaise successfully with clients.

Responsibilities:

  • Produce and amend drawings in line with the site Drawing Management System.
  • Participate in all activities within the drawing office. Ensure that all architectural, electrical, mechanical, civil, instrumentation, general layout drawings are at the correct revision.
  • Ensure that all change management updates are captured and reflected on the appropriate drawings.
  • Ensure that drawing documentation packages issued from projects are correct and are in line with site standards.
  • Ensure compliance for all drawings and procedures that fall under the responsibility of the company.
  • Assist with the development of draughting and documentation staff as required.
  • Ensure all drawings are stored correctly in electronic and paper format and that all drawings issued and received by the department.
  • Carrying as built surveys of existing P&ID drawings and ensure current drawings reflect the as built site conditions.
  • Work closely with the Drawing Office Manager and Engineering Project Teams to develop solutions.
  • Ensure all activities are carried out in line with Company QA & EHS Requirements and Procedures. Play an active role in the CAD Standards/Standard Operating Procedures input.

 

Minimum Qualifications and Experience:

  • Minimum of Higher National Diploma or Higher National Certificate qualification in Engineering.
  • 5+ Yrs Industry Experience with 3+ Yrs working in a similar role.
  • Minimum of 5 Yrs Experience with using AutoCad.
  • Good Written and verbal communication skills.
  • Interact with above site personnel to understand changes and promote the site.
  • Solid engineering acumen.
  • Demonstrated capability to communicate effectively across multiple teams.
  • Good knowledge of GMP / FDA regulatory requirements and current Health and Safety Regulations legislation.
  • Excellent presentation and written / verbal communication skills.
  • Team player, with a flexible approach.
  • Ability to work autonomously.
  • High Attention to detail and accuracy.
  • Experience with 3D modelling software packages would be an advantage.
  • The ability to meet deadlines.

 

11306 – Finance Support Admin - Dublin

Purpose:

Areas to be supported include overall project management, SAP migration, payroll and other Finance processes. The role reports to the company’s Ireland Finance Director.

Responsibilities:

  • Assist in project management for legal entity separation, SAP migration and payroll cut over.
  • Supplement existing company Ireland Finance teams (Accounting, Treasury & Tax, and Payroll) as needed.
  • Participate in SAP migration activities including data structure and configuration planning and end user acceptance testing.
  • Assist the Payroll team to manage new payroll instances for conveyed employees to legal entities, and to implement the new payroll model.

 

Minimum Qualifications and Experience:

  • 5+ years’ experience.
  • A flexible approach to work, ability to multi-task, prioritize and execute within deadlines.
  • Experience in project teams, project management experience desirable.
  • Experience with SAP ERP systems.
  • An understanding of payroll processes, tax and legal framework and IT systems is desirable.
  • Data consolidation and validation experience with excellent attention to detail.
  • Advanced Excel (VLOOKUP’s and pivots) are beneficial.

 

11276 – QA Specialist - Cork

Purpose:

Work with the Integrated Process Team (IPT) compliance group, to maintain all aspects of compliance, within the Vaccine IPT team. This will require a substantial amount of his/her time engaging and communicating with all team members, within the various areas. Leads GEMBA walkdowns frequently, ensuring that areas are always audit ready. Through collaborative and open dialogue, coach area owners in the compliance requirements. Assist them in formulating corrective plans where required, putting a process in place, confirming that actions are addressed. Ensures the highest Quality, Compliance and Safety standards. The Compliance Specialist helps to mould the culture to one that supports a High Performance Organisation.

Responsibilities:

  • Supports the Vaccine IPT compliance plan and generation of quality metrics.
  • Complete review and approval of IPT documentation.
  • Tracking and directing follow-up activities, to correct any non-conformity.
  • Leads GEMBA walk downs.
  • Participate in the preparation and hosting of regulatory and customer audits.
  • GMP training delivery to IPT personnel.
  • Investigation of Minor Deviations.
  • Provide Compliance guidance to Operating procedures.
  • Review Deviation Trends and identify effective CAPA’s, where necessary.
  • Member of the site Permanent Inspection Readiness (PIR) team, ensuring that the Vaccine IPT department is Permanently Inspection Ready.
  • Proactive monitoring of CAPAs, to ensure holistic trends are proactively resolved.
  • Participates in the overall CAPA effectiveness programme and continued improvement on root cause analysis and follow-up CAPA.
  • Participates in Quality Risk Management.
  • Optimises existing operations and practices with a focus on continuous improvement initiatives.

 

Minimum Qualifications and Experience:

  • 3rd Level Degree in Science/Engineering.
  • 1-3 years’ experience in Biopharmaceutical or Pharmaceutical industry.
  • >1 year experience in a Quality / Operations role.
  • Demonstrated technical knowledge and experience in compliance (GMP, Engineering, Technical.)
  • Desirable: Evidence of Continuous Professional Development.
  • Knowledge of and experience in applying Lean Six Sigma and Lean methodologies (e.g. 6S.)
  • Company and site quality policies, procedures and guidelines.
  • Relevant GMP standards.
  • The Quality System.
  • Site procedures and policies.
  • Understands key business drivers and uses this knowledge to make decisions and prioritise.
  • High level of skill in Technical Report writing.
  • Demonstrated ability to coach and influence others, within the Vaccine IPT.
  • Demonstrated ability to initiate and complete Continuous Improvement initiatives.
  • Leads Cross-Functional projects and initiatives, as assigned.
  • Demonstrated ability to identify issues and provide possible alternatives and solutions, both individually and working cross-functionally.
  • Good Organisation Skills. Ability to manage multiple priorities and to know when to escalate issues for resolution (time management.)
  • Proven ability to work as part of a highly motivated team.
  • Communication skills, both written and oral, including persuading others.
  • Good presentation skills. Advanced PC skills such as Excel, Word, PowerPoint.

 

10219318 - Packaging Operations Associate – Dublin

Responsibilities:

  • Ensure all training on equipment, processes, and facility and safety procedures are maintained and up to date at all times.
  • Perform day-to-day manufacturing and cleaning activities to meet schedules while maintaining a high level of GMP compliance.
  • To aid with troubleshooting and resolving operational problems during packaging.
  • Ensure all documentation is completed to the required standard and within the specified timelines.
  • Review batch records and other manufacturing process records as required.
  • Routinely draft and revise standard operating procedures and master batch records.
  • To aid in deviation investigations and closures.
  • Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved.
  • Maintain a high, and continuously improving, level of GMP compliance to ensure patient safety and to minimize risk to the company business.
  • Support Regulatory licensure activities, including agency inspections.
  • Report to Area Supervisor on a regular basis on line performance and report any issues that need to be resolved.
  • To train and be cross functional across all manufacturing areas of the packaging and warehouse facility.
  • To perform any other task or duties as assigned by Area Supervisor.

 

Minimum Qualifications and Experience:

  • Third Level qualification in a scientific or engineering discipline or equivalent experience would be desirable.
  • 2-5 years’ experience in Packaging Operations in a GMP environment.
  • Must be able to work within and adapt to complex electronic systems such as SAP.
  • Experience with warehouse equipment and systems preferred.
  • Should be knowledgeable of regulatory and GMP requirements.

 

11339 - Laboratory Validation Engineer – Tipperary

Purpose:

The Analytical Development and Commercialisation (ADC) department is responsible for all analytical support to the site. This involves testing of raw materials, Excipients, Components, intermediates, Drug Substance and Drug product. We are currently recruiting for the position of Instrument/Validation Specialist in support of these activities. The position reports to the Laboratory Systems Lead. The position offers the opportunity to work with a team of professionals in a modern analytical laboratory using the most up to date technology and quality assurance procedures. The laboratory operates under Lean principles and employees the use of a wide variety of analytical techniques.

Responsibilities:

  • Souring and procurement of Analytical Laboratory instrumentation.
  • Responsible for the execution of the yearly Laboratory Capital Equipment Installation plan.
  • Responsible for the generation and completion of SDLC Validation documentation for new equipment and COTS based computerised system introduced to the site.
  • Maintaining Analytical Laboratory instrumentation in validated state to support testing activities in accordance with site schedules and company policies, procedures and guidelines.
  • Support the introduction of new technology and instrumentation to the site with a focus on Data Integrity principles.
  • Responsible for the decommissioning of all equipment as appropriate.
  • Be part of a dynamic team responsible for Data Integrity requirements for all computerised and non-computerised systems across all the laboratories.
  • Aid in the resolution of issues that may arise during laboratory instrument qualification and use.
  • Participate in assigned improvement projects.

 

Minimum Qualifications and Experience:

  • Degree in Science (Chemistry, Physics or related Life Science) and/or relevant experience.

 

11310 – QA Specialist - Tipperary

Purpose:

The team is the Global Development Quality (GDQ) team which is a group within MRL and is involved in supporting the global GMP Quality Assurance activities for the IMP Licence at the site. Using this site licence we release all Clinical lots to Clinics in the EU and Rest of World. We currently have a team of 13 (8 Quality Specialists, 4 QPs and another heading up the team.) We work closely with similar teams in London, Switzerland and US in these activities to maintain the Clinical Supply Chain for the company.

Responsibilities:

  • Complete auditing/ review of batch documentation to ensure compliance to SOPs, GMPs and applicable regulations.
  • Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
  • Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities.
  • Utilise this network to help resolve comments and issues that arise during audit and review.
  • Manage product recalls and stock recoveries as appropriate.
  • Identify compliance gaps and make recommendations for continuous improvement.
  • Create and maintain assigned SOPs.
  • Perform and review complaints and deviation investigations, change controls and CAPA’s.
  • Generally, follows standard procedures and consults with manager/supervisor to ensure resolution of exceptions.
  • Compile data for reports and presentations, provide data interpretation, draw conclusions.
  • Carry out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
  • Keeps abreast of cGMP requirements as described in applicable worldwide regulations.
  • Represents department on cross functional teams.
  • Additional activities as assigned by the manager/supervisor.

 

Minimum Qualifications and Experience:

  • The Specialist is required to possess a degree in a Quality, Science or Engineering discipline and potentially a higher degree and/or significant industrial experience.
  • They must possess a minimum of 3 years industrial experience.

 

 

11307 – Analytical Chemist – Cork

Purpose:

The Process Sciences team require a Technical Specialist with strong analytical and in process analytics experience to provide multidisciplinary expertise and technical support to the team. The successful candidate will be responsible for assisting in the effective and efficient execution of analytical test methods and for supporting analytical continuous improvement projects. The candidate will also be an active member within the Process Sciences group supporting the efficient & safe operation of the Process Sciences Lab. A high level of innovation, enthusiasm and drive will be required to deliver technical excellence to support high throughput demand on Process Sciences analytical support. The candidate is required to work with moderate work direction and is skilled and knowledgeable to the position.

Responsibilities:

  • Good knowledge of protein chemistry and analytical techniques particularly HPLC.
  • Perform laboratory experiments required to deliver on project timelines.
  • Participate in continuous improvement initiatives, including method optimisation and troubleshooting.
  • Support small scale analytical test method optimisation activities.
  • Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
  • Participate in cross-functional problem-solving teams for troubleshooting and investigations and Quality functions.
  • Support lab compliance with site safety and environmental standards.
  • Prepare and review of technical documents, procedures, metrics, etc.

 

Minimum Qualifications and Experience:

  • MSc/BSc. qualification (Science.)
  • At least 2 years’ experience in an analytical/ small scale process development role in QC or an analytical/process development group.
  • Experience with ASTRA & EMPOWER software, Agilent/Waters HPLCs preferred but not required.
  • High level written and verbal communications with advanced PC skills.
  • Self-motivated and ability to work as part of a team with good project management skills.
  • Demonstrated ability to fully realize improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, problem solving teams etc.

 

 

11296 - Maintenance Tech – Carlow

Purpose:

Responsible for maintaining and troubleshooting process devices, instrumentation and controls in support of vaccine manufacturing. Ensure that objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to our customers.

Responsibilities:

  • Provide effective technical support to Production in all aspects of machine and equipment maintenance, installation and modification; perform detailed maintenance, calibratons, PMs and troubleshooting. Required to operate and clean the process equipment as necessary.
  • Maintain process and production equipment, ensuring ongoing preventative maintenance, equipment troubleshooting and repairs to ensure continuous, reliable and repeatable operation of all equipment; drive Total Productive Maintenance. Ensure effective management and equipment shutdown scheduling, ensuring resources are available, thereby minimizing downtown.
  • Support maintenance planning and preventative maintenance through completion of planned and emergency work orders, calibrations, PMs etc. Document maintenance work, including upgrades, made to existing equipment, including preventative maintenance performed and parts used, to ensure appropriate documentation and records of repair history.
  • Operate and monitor production support equipment, using MES/DCS and PLC based systems, to ensure optimum equipment uptime and target outputs, whilst facilitating continuous process improvements using Lean Principles.
  • Operate, troubleshoot and repair complex systems which may include CIP, Autoclaves, Glassware Washers, production vessels, HVAC, Isolators, compressed gasses, plant steam/condensate, bulk chemical distribution and waste water treatment under minimal supervision in a highly regulated, cGMP environment. Interpret P&ID’s, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs.
  • Support continuous improvement by leading and active participation in repairs, upgrades, preventative maintenance and system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Perform root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement subsequent corrective action through the change management system.
  • Supply information and technical data for securing spare parts and equipment asset entry into the CMMS; liaise directly with vendors on supply of parts, upgrades to systems etc as necessary. Assist in general facility up keep and provides responsive customer support with emphasis on customer satisfaction.
  • Participate effectively in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various IPT systems; ensure all work is carried out in line with same.
  • Leadership activities including selection, development, coaching and day to day management.
  • Ensure that the team receives appropriate resources and programmes to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role. Develop and maintain training programmes.
  • Required to comply with company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.

 

Minimum Qualifications and Experience:

  • Leaving Certificate or equivalent required.
  • Time serviced Apprenticeship or equivalent Certificate/Diploma in an Engineering or related discipline is required.
  • Would typically have prior related work experience; ideally in a manufacturing, preferably GMP setting Troubleshooting and maintaining process instrumentation and equipment.
  • Understanding of mechanical/electrical/Instrumentation / pneumatic processes.
  • Sterile filling processes.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Report, standards, policy writing skills required.
  • Proficiency in Microsoft Office and job related computer applications required.
  • Lean Six Sigma Methodology experience desired.
  • Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers.

 

 

10203763 – QC Compliance Optimisation Specialist - Athlone

Purpose:

The company’s Athlone Quality Control is a growing department with responsibility for in-process testing and environmental monitoring. This position is responsible for actively identifying opportunities for process and compliance improvement and translating these into practice. In this role, you should have excellent relationship building and problem-solving skills. A high attention to detail and excellent verbal and written communications skills are vital to success in the role.

Responsibilities:

  • Support implementation of effective shift handover/QC internal communication.
  • Identify and implement improvements to Lab Processes, Layout/flow and 6S type activities.
  • Training – design of induction training to lab, up to area SME level – define the training requirements and implement simplified training program.
  • Planning, scheduling and facilitating continuous improvement workshops and translation of the output to procedural/process updates.
  • Documentation flow and paperwork practices – Improving Right First Time and reducing GDP errors within QC and implementing processes to track and trend performance against targets.
  • Develop simplified and effective scheduling for routine/non routine activities to maximise available resources.
  • Implementation of real time review and real time trending of all QC data.
  • Support Implementation of in-house microbial identification using the Vitek including the design of process, documentation and training program.
  • Maintain regular and proactive communication with all stakeholders.

 

Minimum Qualifications and Experience:

  • Degree in science/pharmaceutical related subject.
  • At least 10 years’ working in a GMP Quality Control Laboratory.
  • Knowledge and understanding of GMP/GDP standards.
  • Strong problem solving and leadership experience.
  • Experience in workshop facilitation.
  • Experienced in leading and executing continuous improvement initiatives.
  • Experience of SOP authoring and document management processes.
  • Highly Computer literate, with MS Office (Word, Excel.)
  • Experience of provision training to others.
  • Good working knowledge of QC Microbiology and Chemistry instrumentation and methods.
  • An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.
  • Excellent communication & presentation skills are essential.
  • Excellent time management organizational skills along with a proven ability to multi-task.

 

 

11266 – Technical Specialist (Materials Review Board) - Cork

Purpose:

The Materials Review Board Technical Specialist will become a key team member of the newly formed Material Review Board Team within the Technology Center of Excellence Department which provides technical expertise to a growing site with an expanding portfolio of technologies and products. The successful candidate will work in a dynamic environment with exciting career opportunities. The Materials Review Board Technical Specialist will deliver on timely implementations of Supplier Change Notifications by conducting detailed technical assessments of the change , while working collaborative with all internal departments and external partners, to meet the company Manufacturing Division Priorities of: Compliance, Supply, Strategy and Profit Plan. The Materials Review Board Technical Specialist is responsible for actively participating in the Tier process to manage supplier changes and proactively manage and resolve issues before they impact the business priorities. The Materials Review Board Technical Specialist will model the company Leadership behaviours and understand the MPS principles to drive a culture of continuous improvement building a High Performance Organisation. The Supplier Change Control Specialist will participate and comply with the company Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant to you.

Responsibilities:

  • Be the main point of contact within the team for Supplier changes assigned to them and to to ensure that key stakeholders are kept informed throughout the change control lifecycle process and that both internal & external expectations are managed.
  • To lead the full and detailed assessment of the impact of the proposed Supplier change(s) from a Safety, Quality, Technical and Supply perspective with the appropriate support from internal departments.
  • All necessary internal check are performed and that the identified tasks are fully completed before the Supplier proposed change is approved whilst ensuring adherence to internal change control procedures.
  • Coordinate and prioritize multiple Supplier change controls notifications to ensure they are delivered in a timely fashion while ensuring the highest Quality & Compliance standards throughout the process.
  • Provide ongoing input and support to the MRB team members, support continuous process improvement initiatives, share their technical knowledge and promote best practices.
  • Responsible for prioritization of their proposed mitigation plans and/or acceptance of Quality Risks identified as part of the Quality Risk Management Process under the remit of their role and responsibility.
  • Support the building and fostering relationships with internal and external stakeholder.
  • Ensure timely completion of Supplier change control tracker to help the team track the overall MRB process against committed timelines.

 

Minimum Qualifications and Experience:

  • Degree in Science or Engineering discipline (preferably MSc.)
  • At least four to five years’ experience in the Pharmaceutical industry or a similar operating environment with experience in a Technical Role in a manufacturing environment.
  • Knowledge of Single Use Technology is an advantage.
  • Experience dealing with external suppliers/ partners.
  • Works independently with all levels of the organization.
  • Demonstrated knowledge in one or more pharmaceutical and/or chemical manufacturing operation (e.g. manufacturing, quality, engineering, etc.)
  • Knowledge of and experience in applying Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements.
  • Demonstrated leadership skills with a continuous improvement focus.
  • Knowledge of Project Management skills for leading projects.
  • Process and technology background desirable.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
  • Demonstrated level of problem solving and facilitation skills.
  • Advanced PC skills such as Excel, Word, and PowerPoint.
  • Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
  • Desirable to have some working knowledge of Trackwise, SAP, MIDAS (but not essential.)
  • Desirable evidence of Continuous Professional Development.
  • Desirable for Six Sigma Green Belt.
  • Desirable project management qualification such as PMP etc.

 

 

11277 – Data Integrity Lead - Dublin

Purpose:

The Data Integrity Lead will be responsible for implementing the site Data Integrity Strategy ensuring objectives are effectively achieved, consistent with the company’s requirements to ensure compliance, safety and reliable supply to our customers.

Responsibilities:

  • Lead Data Integrity (DI) activities at Biotech Dublin for all systems – Laboratory, Manufacturing and IT.
  • Lead business process design efforts relating to DI solutions.
  • Chair the site DI council.
  • Coach and mentor a matrix team to deliver on the DI strategy.
  • Development and leadership of a governance structure to allow for sponsorship and partnership of the site Snr leadership team and global centres of excellence.
  • Ensure that all project milestones for DI are met.
  • Support DI training on site as required to up skill and increase DI awareness.
  • Complete periodic DI audits across the site.
  • Manage change execution for DI related changes.
  • Maintain the site DI communications board.
  • Be the primary liaison between site and the global DI COE.
  • Participate and attend Global DI CoE workshops as applicable.
  • Participate in additional training on data integrity and industry requirements as required.
  • Represent the site at the DI Communities of Practice to support sustained alignment across our manufacturing division network.
  • Lead communications to the sustaining sponsors, senior leadership and department leadership teams as appropriate.

 

Minimum Qualifications and Experience:

  • BSc (or equivalent experience base) in Science/Engineering or a related discipline.
  • A minimum of 8 years’ experience in a pharmaceutical environment.
  • A minimum of 2 years’ Quality experience.
  • Knowledge of relevant GMP and DI standards.
  • Deep understanding of current regulatory requirements and expectations.
  • Validation of IT systems.
  • Auditing of IT systems.
  • Strong scientific understanding.
  • Knowledge of relevant regulatory requirements for DI, including GMPs.
  • Skilled Change Manager.
  • Planning and Scheduling.
  • Strong DI/IT knowledge/abilities.
  • Ability to interact with multiple stakeholders across numerous departments.
  • Ability to work independently and as part of a team.
  • Excellent communication skills and the ability to work in a cross functional collaborative environment.
  • Demonstrated problem solving skills.
  • Continuous improvement skills.
  • Planning and Scheduling.
  • Excellent project management skills.
  • Expert knowledge of GMP/Data Integrity and experience with regulatory inspections is required.
  • Assertive and a very strong communicator who can develop contacts internally and external to the network.

 

 

11208 – Compliance Specialist – Safety & Environmental - Cork

Purpose:

To implement, audit and advise on company EHS policy, to ensure the safe operation of the Vaccine IPT and the health and safety of its employees and the prevention of any environmental excursions or notices of violation. To promote EHS management systems, business continuity, regulatory compliance, community, company image/reputation and performance within Vaccine IPT, promoting alignment with global EHS strategies and objectives. The Compliance Specialist, Safety & Environment, is accountable for the smooth execution of all appropriate functions, associated with EHS, within the Vaccine IPT. The Compliance Specialist, Safety & Environment will participate and comply with the Global Safety and Environment Management System and the company Quality Management System (QMS) requirements, including ownership, as relevant.

Responsibilities:

  • Supports Corporate and Vaccine IPT EHS strategy and objectives, contributes to development and implementation of global EHS programs and promotes local alignment with same.
  • Promotes culture of EHS excellence at the facility and provides high-quality safety, health and welfare technical leadership, to the Vaccine IPT.
  • Addresses risk prevention opportunities, including hazardous materials exposure, spills, releases, accidents, fires, or other unsafe conditions.
  • Manages EHS risk profile for the Vaccine IPT.
  • Optimizes existing operations and practices with focus on continuous improvement initiatives.
  • Provides oversight on EHS projects for the Vaccine IPT.
  • Conducts annual self-assessments, and more frequent EHS audits, tracking and directing follow-up activities to correct any non-conformity.
  • Creates and maintains databases & records, containing pertinent EHS metrics and data.

 

Minimum Qualifications and Experience:

  • 3rd Level degree in EHS, chemical engineering or other related discipline (chemistry, physical sciences or biology) is required. Other 4-year degree health/sciences with significant equivalent work experience in EHS field may suffice.
  • Graduate degree preferred.
  • Professional certifications in related disciplines and/or advanced degree in EHS management are a plus.
  • Demonstrated knowledge in more than one Biopharmaceutical and/or pharmaceutical manufacturing operation (e.g. Manufacturing, Quality, Engineering, Tech Services etc.)
  • Typically, will have experience in EHS and/or engineering related positions, including knowledge of biopharmaceutical, pharmaceutical, chemical, research and development processes is desired.
  • Knowledge of and experience in applying Lean Six Sigma and Lean methodologies (e.g. 6S.)
  • Working cross-functionally, identifies EHS problems and provides possible alternatives and solutions.
  • Provides technical expertise in investigation of problems and develops innovative solutions, implementing corrective and preventive action plans to address problems.
  • Handles ambiguous and complex issues as they arise.
  • Initiates and takes responsibility for his/her own professional development.
  • Position may directly or indirectly supervise others.
  • Trains, develops, and coaches staff as well as monitors their output and performance, as applicable.
  • Leads cross-functional projects and initiatives as assigned.
  • Demonstrated ability to initiate and complete Continuous Improvement initiatives.
  • Desirable: Evidence of Continuous Professional Development.
  • Desirable: Six Sigma Green Belt.

 

 

10016773 – Supply Chain Distribution Specialist - Dublin

Purpose:

Responsible for managing and executing end-to-end Logistics processes for the shipment of products from our Manufacturing sites (internal and external) and distribution centers to the final delivery location. In this role, you should have strong logistics experience, problem-solving skills, with a high attention to detail and an excellent communicator both verbal and written with a focus on customer centricity.

Responsibilities:

  • Fully compliant with internal SOP’s, standards and associated training.
  • Coordination and execution of Product shipments across our Global Network (Primary & Secondary nodes.)
  • Manage operational logistics to ensure on-time delivery with no interruption to supply across our Global Network.
  • Support the strategic objectives of the organization focusing on optimizing the logistics network.
  • Manage aspects of the daily compliance requirement.
  • Creation of GMP and non-GMP documentation including procedures, specifications and shipping documentation across Global Logistics.
  • Responsible for CAPA’s, Change Controls & Deviations program and initiate Corrective Action plans in the company’s Quality Management System, TrackWise.
  • Coordinate introduction of new shipping lanes for new and existing products from commercial launch and clinical to commercial activities with validation SME’s.
  • Maintain regular and proactive communication with all internal and external stakeholders to ensure efficient execution of schedules.

 

Minimum Qualifications and Experience:

  • Degree in Business Management, Supply Chain/Logistics, or related field experience preferable.
  • At least 5 years’ working in Pharmaceutical Supply Chain Logistics or Operations role within an international environment is essential.
  • Knowledge and understanding of GMP/GDP standards.
  • SAP Knowledge of SD and MM Environment.
  • Computer literate, with MS Office (Word, Excel, Outlook.)
  • Fluency in English both written and oral is essential; fluency in other languages is desirable.

 

 

10118211 – QA Distribution Specialist - Dublin

Purpose:

Position is responsible for the quality oversight of distribution of company products world-wide. Position will execute QA Distribution release of batches at 3PL Distribution centers, ensuring that product shipments are managed in compliance with GDP requirements and applicable company procedures. Position supports company Logistics, Customer Operations and Commercial Distribution functions and in addition provides Quality Management System support to the site for managing quality records.

Responsibilities:

  • Responsible for QA oversight of cold chain activities in all markets in accordance with local and international requirements and company planning schedules; ensure products shipments are managed in accordance with GDP’s requirements.
  • Ensuring QA distribution batch release of shipments at the 3PL Distribution centers.
  • Assess cold chain shipments and provides corresponding quality decision on product.
  • Review documentation including change controls, deviations, validation documentation, SOPs and specifications.
  • Ensure Quality Agreement with company distribution contractors and carriers are established and maintained.
  • Assess and process product returns in conjunction with the company’s Logistics team.
  • Provide Quality and compliance support to projects impacting Distribution site activities.

 

Minimum Qualifications and Experience:

  • Degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering.)
  • 3+ years QA experience in a HPRA/FDA/EU & GDP regulated environment.
  • Knowledge of Cold Chain activities.
  • Knowledge of GDP and global regulatory requirements.
  • Sound awareness and understanding of pharmaceutical and biotech business, especially with regards to quality and regulatory requirements.
  • Strong Interpersonal skills and ability to interact constructively with all functions in a matrix organization environment.
  • Good verbal and written communication skills with well-structured communication and ability to present to various audience levels.

 

 

11269 – C&Q Project Manager - Carlow

Responsibilities:

  • Reporting to GES C&Q Lead EMEA as part of a multi-discipline team responsible for Commissioning & Qualification (C&Q) activities on a multi-product facility.
  • Project Manage the day to day C&Q activities of the C&Q team.
  • Liaise with Project Controls function.
  • The candidate will be a convincing communicator with strong interpersonal skills
  • This candidate will be required to work closely with a cross-functional team and coordinate activities between Construction, Process, Technical Operations, IPT and QA.
  • Report to GES C&Q EMEA Lead / Project Manager on the given project.
  • Support all suite teams during a commissioning and qualification program.
  • Assist the C&Q Technical Lead in the planning and tracking of activities.
  • Actively support Last Planner System activities.
  • Liaise with the various stakeholders on the C&Q team and the overall project to ensure clear communication between all parties.
  • Participation in C&Q activities, as required.
  • Review and Input into deliverables such as technical requirement specifications and vendor turnover documentation.
  • Participate in C&Q deliverables (System Impact Assessment, Critical Component Impact Assessments, System Boundary Drawings, Requirement Traceability Matrix.)
  • Manage generation and execution of C&Q documentation (FAT, SAT, IOC, DQ, IQ, OQ, IOQ) for the project based on available approved client templates & design documentation.
  • Monitor and report on approval of C&Q documentation.
  • Monitor and report review of CCRs and TOPs.
  • Participate in C&Q change controls (FDCNs and PCNs) and drive their closure in a timely manner. Ensure non-conformances & deviations are minimised and closed out in a timely fashion.
  • Support system P&ID walkdown with construction prior to handover. Categorisation of punchlist items & tracking to completion.
  • Support review on all Isometrics, Weld logs, Weld Qualifications, 3rd Party Inspections, Material of Construction and Redlining exercise.
  • Facilitate/expedite Mechanical Completion in conjunction with the Construction team. (Liaise with construction contractors towards successful completion of Construction Turn Over Documentation.)
  • Pre-start up safety checks, LOTO & ensuring timely loop checking and calibrations.
  • Coordinate and supervise third party vendors during SAT execution. Review and approve SAT protocols.
  • Attend daily communication meetings with suite teams, as required.
  • Assist in investigations of process equipment, utility systems, and control system anomalies, as well as safety incidents.
  • Maintain a clean and safe working environment by enforcing procedures, policies, and regulations.
  • Implement company GES C&Q strategies as set out by the GES C&Q Lead EMEA.
  • Ensure that system delivery progresses in accordance with the approved project schedule.
  • Notify C&Q Technical Lead, in a timely manner, of all relevant issues which may impact on system progress.
  • Ability to work in design and construction project environment within Ireland.
  • Coordinate with design and/or project teams to resolve any identified technical issues.
  • Organise / attend all coordination meetings necessary to progress the job.
  • Possess good communication skills.
  • Ensure that all works carried out in C&Q scope or responsibility by construction, commissioning and contract team members are performed in accordance with site safe working practices.
  • Ensure the cohesive operation of cross-functional team and coordinate work for effective and efficient completion.

 

Minimum Qualifications and Experience:

  • Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.
  • Minimum of 5 years’ experience in commissioning and/or validation of USP/DSP/Facilities/Utilities systems within Pharmaceutical industry.
  • Technical knowledge of black utilities and clean utilities systems and equipment, biotechnology processes and a working knowledge of FDA and EU regulations is preferred.
  • Knowledgeable with latest industry standards and guidelines on C&Q, including ISPE/ASTM.
  • Strong interpersonal and communication skills (verbal/written.)
  • Experience in C&Q as a C&Q Lead/Project Manager on a major capital project.
  • Working knowledge of process control systems and automation. DeltaV, syringe & vial line experience beneficial.
  • Knowledge of C&Q documentation required for cGMP process equipment.
  • Fluent in English, written and verbal.
  • Ability to understand project plans and schedules.
  • Working knowledge of word processing, spreadsheets, database management software, CAD software, and PCs.
  • Knowledge of regulations and standards affecting devices, biologics and pharma products.

 

 

10755 – Validation Engineer - Cork

Purpose:

The Validation Engineer/ Technical Specialist will be required to collaborate and facilitate running of activities (PPQ batch manufacture, validation activities, investigations, change control) in the Vaccine IPT to ensure the effective and efficient on-time delivery of these activities for the Vaccine IPT. This requires the delivery of technical excellence to deliver components of a stable process, supported by a flexible, collaborative, multi-skilled teamwork environment.

Responsibilities:

  • Ensure the highest Quality, Compliance and Safety standards primarily not only with Technical/Validation activities but relating to all activities to enable the team’s performance in the Vaccine Technical group within the Vaccine IPT.
  • Project validation support including conducting equipment performance qualifications (cleaning and sterilization validation periodic reviews, re-qualifications, temperature mapping.)
  • Authoring project validation master plans, SOP and documentation updates, authoring validation protocols and final reports, executing validation studies, analysis of validation data.
  • Resolving technical issues encountered during study execution. Lead and close process related deviations and reports and participate in problem solving teams across all areas of the Vaccine IPT (e.g. reliability, Safety, Quality (e.g. CAPA/DN/MDNs etc.)
  • This individual will be required to work in a cross-functional team and independently to accomplish validation project objectives.
  • Experience with audits and preparation for audits.
  • Works with moderate work direction and is skilled and knowledgeable to the position.
  • Responsible for the technical support of manufacture in the Vaccine IPT.
  • Technical review, ownership of and approval of Global Change Management records as required.
  • Recommend technical approaches in line with global and local standards.
  • Contribute for driving a culture of Continuous Improvement by deploying Our Company Six Sigma tools and MPS within the IPT on projects such as: problem solving, reducing cycle time, lean principles within the new processes.
  • Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
  • Participate and comply with the Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

 

Minimum Qualifications and Experience:

  • Degree or Masters in a Science or Engineering discipline (preferably Biotechnology.)
  • Preference for Lean Six Sigma qualification or experience of application of Lean principles.
  • Project management qualification such as, Project Management Professional is desirable.
  • Evidence of Continuous Professional Development.

 

 

10069 – Process Engineer - Carlow

Purpose:

Responsible for providing process, technical, and validation support operations including ongoing support of manufacturing processes and support for new product introduction. Accountable for analytical/engineering studies associated with the development of new components, products, processes systems and facilities. Co-ordination, design and execution of equipment qualification. and validation as required.

Responsibilities:

  • Serve as technical and/or validation support as required for manufacturing and new product introduction.
  • Design/Author/Review/Approve/Execute process development studies in support of new product introduction and ongoing manufacturing support.
  • Provide technical input into quality notification by authoring/reviewing/approving investigations.
  • Execution of equipment commissioning and qualification programs.
  • Execution of equipment/qualification validation programs; including re-qualification and revalidation.
  • Design/Author/Review/Approve/Execute qualification/validation documentation and studies in line with the standard approval process.
  • Perform data analysis and make informed decisions/recommendations around conclusions reached from data analysis.
  • Support continuous improvement through Lean Six Sigma methodologies.
  • Leading and active participation in projects, system failure investigations and investigation reports.
  • Execution/development of change controls.
  • Contribution to Kaizen events as appropriate.
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.
  • Implement subsequent corrective action through the change management system.
  • Serve as technical engineering representative for internal technical group discussions and represent the company at global technical forums.
  • Participate and/or lead cross functional or single function teams including liaising with vendors or above site groups.
  • Drive compliance of company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made. Accountable for compliance via documentation completion, risk assessments, closing out corrective action, participate in audits and inspections and proactively highlighting any issues around compliance.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.

 

Minimum Qualifications and Experience:

  • Bachelor’s Degree or higher preferred; ideally in a Science, Engineering or other Technical discipline.
  • Relevant experience and a particular skill set in their area of expertise that adds value to the business; ideally in a manufacturing, preferably in a GMP setting.
  • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  • Report, standards, policy writing skills required.
  • Equipment and process validation.
  • Sterile filling processes and equipment.
  • Proficiency in Microsoft Office and job related computer applications required.
  • Lean Six Sigma Methodology experience desired.

 

 

11258 – Utilities Engineer - Cork

Purpose:

Reporting to the Utilities Lead, the purpose of this role is to be a Process Engineer supporting the WWTP. This is a key role to ensure that the day to day operations of the Utilities are provided to the WWTP to ensure compliance. This role provides operational, quality, utility, environmental, safety and waste water treatment services and expertise to WWTP to enable the manufacture of quality pharmaceutical products in accordance to meeting the company Priorities of: Compliance, Supply, Strategy and Profit Plan.

Responsibilities:

  • Ensure highest Compliance (Safety and Environmental) standards with site IED License, Corporate policies, global standards, and procedures for WWTP.
  • Management of day to day operations of WWTP operations.
  • Ensure WWTP equipment availability, maximise performance of WWTP operations and identify / implement continuous process improvement initiatives.
  • Streamline and optimize WWTP plant processes.
  • Be an active participant within the Utilities Engineering team sharing Engineering best practices.
  • Promote a culture of EHS excellence and provides high-quality safety, health and environmental technical leadership to assigned projects.
  • Attending daily Tier meetings and follow-up.
  • Assists in the management the site’s periodic EHS Self Assessments programme to assure conformance with Site, Corporate and/or Statutory EHS requirements.
  • Responsible for investigating EHS Incidents related to the WWTP.
  • Attending and responding to relevant Hazop studies and completion and follow-up of specific risk assessments.
  • Responsible for representing WWTP for both internal and external audit inspections.
  • Delegates for Utilities Lead as required.
  • Provide environmental and EHS support for projects.
  • Operate in full compliance with site, industry and EPA requirements in waste water treatment and disposal.
  • Participate in efficiency and streamlining projects which contribute to site initiatives and contribute to increased safety, process improvement cost saving etc.
  • Responsible for supporting a culture of Continuous Improvement by deploying company Six Sigma tools such as Lean principles within the WWTP area.

 

 

Minimum Qualifications and Experience:

  • Degree or 3rd Level Qualification (Process/ Mechanical Engineering or EHS Environmental), Desirable Masters qualification (specifically environmental.)
  • >3 years’ experience operational experience in WWTP plant environment with experience in the utility management, Waste water treatment, safety and environmental compliance.
  • WWTP process and technology background: the successful candidate will understand how to drive optimization.
  • Demonstrated ability to realize improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team, etc.
  • Demonstrated high level of problem solving, innovation and facilitation skills.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Experience with Management Systems such as SAP, EHS, Microsoft PM, etc.
  • High level of knowledge of Safety, Quality and Environmental requirements.
  • Excellent verbal and written communication skills (includes ability to write standard operating procedures and work protocols.)
  • Ability to plan, prioritise and effectively manage time, meet deadlines and produce quality deliverables.
  • Demonstrated experience of stakeholder management of multiple decision makers, cross functional teams.
  • Desirable Lean Six Sigma Green Belt Qualification.
  • Results and performance driven.
  • Adaptive and flexible.

 

 

10120867 – Planning Specialist - Dublin

Purpose:

Position drives the planning of Working Cell Bank, Drug Substance, Drug Product and Finished Product production schedules for the internal and external manufacturing sites to ensure product needs of Commercial and Clinical Operations are met for all Complement products. Provides both short and long term planning oversight and optimization of product inventories, manages data, and provides reports to internal and external leaderships teams. The successful applicant will have very strong leadership competencies and capabilities and therefore possess the capability to progress through the organization into roles of increasing responsibility in the future.

Responsibilities:

  • Provides short and long term planning oversight and optimization of inventories of working cell bank, drug substance, drug product and finished product in the relevant suppliers, countries and distribution centers, including New Product Introduction.
  • To perform key scenario planning analysis based on supply chain challenges for GSC Leadership team review.
  • Drives the commercial demand review process with relevant commercial stakeholders.
  • Supports reconciliations for all stock locations and provides end of month data/reporting to Corporate Finance and External Audit Partners.
  • Work closely with regional commercial partners to understand sales forecasts, both performance against plan and anticipated changes, insuring inventory levels and production schedules can support market requirements.
  • Monitors compliance to the plan across the entire supply network.
  • Ensures data accuracy in all aspects of planning, as well as in the global planning ERP system.
  • Support the design and implementation of Supply planning metrics.
  • Ensuring compliance to Standard Operating Procedures and Good Distribution Practices.

 

 

Minimum Qualifications and Experience:

  • Third Level Degree qualification in a relevant discipline is desired.
  • 6 years+ in Supply Planning or associated experience.
  • Advanced level in MS Excel and intermediate level in other MS applications essential.
  • OMP Plus Planning Software Experience essential.
  • Advanced analytical skills and high attention to detail essential.
  • Strong knowledge of Supply Chain Planning concepts and strategies.
  • Prior experience with Advanced Supply Chain Planning Systems essential.
  • Knowledge of planning processes and distribution planning principles.
  • Ability to cope with fast-paced and dynamic business environment.
  • Prior SAP functional skills are preferred but not essential.
  • Familiarity with concepts of cGMP.
  • Ability to communicate and lead cross functional projects.

 

10199917 – Warehouse Associate - Dublin

Responsibilities:

  • Ensure all training on equipment, processes, and facility and safety procedures are maintained and up to date at all times.
  • Perform day-to-day warehouse activities to meet schedules while maintaining a high level of GMP compliance.
  • Maintaining the Warehouse Quality System by adherence to all relevant SOP’s, policies and cGMP requirements.
  • To aid with troubleshooting and resolving operational problems.
  • Act as a subject matter expert for the Warehouse group in relevant equipment and system root cause investigations and fill the role of lead investigator where required.
  • Support continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved.
  • Report to Warehouse Supervisor on a regular basis on area performance and report any issues that need to be resolved.
  • Proactively ensuring that all Environmental, Health and Safety responsibilities are carried out according to EHS regulations and procedures.
  • Maintaining spare parts, change parts etc. in the Engineering Stores.
  • Utilising and maintaining IT systems as required, e.g. SAP.
  • Provide support to Operations, Validation, Engineering and Quality where required.
  • Complete training with new/junior Warehouse Operators.
  • Other duties as required.

 

Minimum Qualifications and Experience:

  • Current or previous formal education in logistics/warehousing/supply chain would be an advantage.
  • 3-10 years’ experience performing Warehouse support activities preferably in a cGMP commercial manufacturing environment.
  • Must be able to work within and adapt to complex electronic systems such as SAP.
  • Good interpersonal, communication and problem-solving skills.
  • Should be knowledgeable of regulatory and GMP requirements.

 

10113135 - Supply Chain Distribution Specialist – Dublin

Purpose:

This position is responsible to co-ordinate the shipping of finished products from internal and external manufacturing sites to primary distribution centres and final mile delivery to customers. Another key component will be management of internal relationships, including cross-functional departments to ensure business success. In this role, you should have strong business acumen, problem-solving skills and attention to detail. Your goal will be to help our Global Logistics function deliver for our patients.

Responsibilities:

  • Coordination and execution of Drug Substance, Drug Product and Finished Product shipments across our Global Network.
  • Manage aspects of the compliance requirement which will include the oversight of the quality records and to identify key area’s for improvement.
  • Creation of GMP and non-GMP documentation including SOPs and shipping documentation across Global Logistics.
  • Fully compliant with internal SOP’s and standards.
  • Participate in projects for continuous improvement related to Global Logistics and Supply Chain.
  • Coordinate introduction of new shipping lanes for new and existing products from commercial launch and clinical to commercial activities with validation SME’s.
  • Maintain regular and proactive communication with all internal and external stakeholders to insure efficient execution of schedules.
  • Identify process improvements within the function and drive the initiative forward to implementation and effectivity.
  • Ensure department deviations are investigated thoroughly and corrective plans put in place to prevent re-occurrence.

 

Minimum Qualifications and Experience:

  • University Degree in Logistics, Supply Chain preferred.
  • At least 5 years’ working in Pharmaceutical supply chain is essential.
  • Knowledge and understand of EMA/HPRA GDP standards.
  • Strong problem-solving experience.
  • SAP Knowledge of SD and MM Environment.
  • Computer literate, with MS Office (Word, Excel, Outlook.)
  • Fluency in English both written and oral; fluency in other European languages is desirable.

 

11238 – Validation Engineer - Carlow

Purpose:

As part of a significant expansion of the site, an exciting opportunity has come to join the Commercialisation team to transition from a project phase to a fully operational facility delivering life-saving products to patients. There are 4 broad technical areas that will require experienced, energetic and committed engineers – (1) Sterilisation – Autoclaves, SIP of vessels (2) Cleaning – Parts Washer and CIP of vessels (3) Vial and Syringe filling operations –Glass handling, Tray & Tub handling, Drug Product Filling and Parenteral Product Visual Inspection. (4) Vial and Syringe Sterility operations – Isolators, VHP, E-Beam and Depyrogenation systems. The successful candidate will need to have demonstrated experience in one or more of these areas.

Responsibilities:

  • Project validation support including conducting equipment performance qualifications (specifically cleaning and sterilization validation.)
  • Authoring project validation master plans; SOP and documentation updates.
  • Authoring validation protocols and final reports, executing validation studies, analysis of validation data.
  • Resolving technical issues encountered during study execution.
  • This individual will be required to work in a cross-functional team and independently to accomplish validation project objectives.
  • Minimal work direction needed, highly skilled and knowledgeable to the position.
  • Within your chosen role you will be acting as a senior engineer reporting within the Technical Engineering department.
  • Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams, attending FAT and design reviews to represent client validation interests.
  • Oversee equipment C&Q within the assigned area with a view to ensuring right first-time C&Q and Validation effort.
  • Act as validation SME on the equipment within the area assigned. As such you will beleveraging testing from Commissioning and Qualification.
  • Providing technical and validation oversight to process, design and project delivery teams and coaching to associate staff within the assigned suite.
  • Implementing the requirements as outlined in the site / project Validation Master Plan.
  • Coordination of engineering sub-teams in the assigned suite during execution of Cycle Development & Validation activities.
  • Authoring and reviewing standard operating procedures and technical reports including PQ protocols.
  • Technical review and approval of Commissioning protocols, Qualification protocols and Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
  • Supporting regulatory submissions as required.
  • Owning Change Management process for Equipment introduction within the assigned suite for qualification / validation up to PQ stage.
  • Effective application of LeanSixSigma and Change Management tools in the Validation group by:
    • Leading by example in achieving results by using industry standard tools and processes.
    • Facilitate problem solving & risk assessment (FMEA) projects/meeting.
    • Make problems visible and strive for continuous improvement.
    • Serving as a key member during internal audits and external inspections/audits.
    • Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
  • Lead and support various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc.)
  • Represent the site in internal collaborations through Manufacturing Division Validation Communities of Practice to include sharing of best practices in validation and investigation activities.
  • Keep up to date with scientific and technical developments, best practices and attend seminars as required.
  • Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
  • Execution in line with the site Continued Process Validation (CPV) program and supporting cross-site CPV as needed.

 

 

Minimum Qualifications and Experience:

  • Engineering or scientific background. Equipment Validation and Sterilization Validation.
  • This role requires an experienced individual with a minimum of 3 years directly related experience in academia, pharmaceutical or biotechnology industry – along with a working knowledge of current regulatory requirements and current Good Manufacturing Practices.
  • Strong technical writing and oral communication skills.
  • They will also have excellent oral and written communication skills, with the ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
  • With relevant technical qualification(s) in Applied Pharmaceutical / Biological / Computer / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
  • The candidate will also show ambition and drive to develop and advance within the role.

 

 

 

9751 – Project Manager Non-IT - Tipperary

Purpose:

Reporting to the Global Engineering Solutions Project Manager. This will be a key role in the GES organization which is currently executing significant Sterile, Pharmaceutical and Chem API projects. The Project Engineer will be a key member of the project management team on a 100MM capital project. The successful candidate will be able to demonstrate a proven track record to lead project delivery efforts and to influence others, be a convincing communicator with strong interpersonal skills and strategic and tactical thinking abilities. Have knowledge of Cleanroom/HVAC/E&I, equipment and utilities systems.

Responsibilities:

  • Assist in the development of project plans and successfully execute them according to established schedule, cost and performance standards.
  • Work closely with EPCM to effectively & efficiently progress the equipment design (dispensing & blending, roller compactor, compression, coating & cleaning.)
  • Manage design, construction, commissioning and qualification, schedule and cost in collaboration with other project team members, company personnel, outside contractors and suppliers.
  • Track and report progress as required against project deliverables.
  • Ensure there is a strong safety culture and performance in the execution of capital projects.
  • Monitor progress of project milestones with all team members and provide status reports. that all project stakeholders are informed and consulted on key project activities, progress and decisions.
  • Develop and maintain appropriate electronic and paper documentation & filing systems to ensure that all project documents are filed during project execution and safely archived following project completion.
  • Ensures that good Engineering practices are utilised and aligned with customer’s needs from requirements gathering, through design and execution.
  • Manage project changes and ensure all are captured, documented and assessed.
  • Manage the execution of Commissioning & Qualification documentation.
  • Manage a change control procedure to the assigned scope.
  • Participate in EPCMv led HAZOP and design reviews as lead GES Representative, ensuring company stakeholder inputs are coordinated and appropriate.

 

Minimum Qualifications and Experience:

  • Must have as a minimum a 3rd level Degree in Engineering, preferably Chemical or Mechanical
  • A minimum of 8 years of relevant experience in project management of capital projects in a high tech industry, preferably in Oral Solid Dosage.
  • Preferable to have a qualification in project management – PMP or equivalent.
  • Proven level of experience in delivering significant capital projects within the pharmaceutical sector.
  • Hands on attitude.
  • Ability to sequence critical activities in planning work for.
  • Ability to coordinate activities to deliver projects to an aggressive schedule.
  • Knowledge of clean room installation an Advantage.
  • Understands the typical project life cycle from concept through to qualification and has proven experience in this area.
  • Familiar with engineering project management tools, financial management skills including an ability to work within budgets, and engineering technical skills.
  • Proven knowledge, appreciation and experience of working in strongly regulated GMP environment.
  • Strong interpersonal skills and an understanding of the customer/client relationship involved in projects.
  • Excellent communication /presentation skills.
  • Superior organizational and planning skills.
  • Demonstrated performance and managing multi-functional teams.
  • Demonstrated experience in leading projects from Design to Qualification.

 

 

11222 – QA Validation Specialist - Dublin

Responsibilities:

  • Act as Quality Assurance approver for qualification/validation lifecycle documents.
  • Serve as a quality assurance resource for assessing validation requirements, non-conformance, impact assessments, root cause analysis and implementation of CAPA found during CQV activities.
  • Will serve as the Quality SME for all validation activities across the site including but not limited to Steam in Place (SIP), Cleaning Validation & CTU (Controlled temperature Unit) Performance qualification.
  • Provide Quality Assurance Validation support for Steam In Place (SIP) of buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains & Autoclave loads.
  • Provide Quality Assurance Validation support for the Cleaning Validation Program. Cleaning (CIP) cycles/ for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers and supporting process equipment.

 

 

Minimum Qualifications and Experience:

  • Bachelor’s degree (or higher) in Engineering, Chemistry, Biology, or relevant discipline, the successful candidate will also ideally have a proven track record in delivering excellence.
  • This role requires a minimum of 3 years’ experience in, Quality Assurance, Technical Operations or Engineering within the Biopharma / Pharmaceutical industry.
  • Must have at least 3 years of experience in commissioning, qualification, and validation activities in in a regulated environment.
  • Experience working in regulated environment with exposure in the Regulations & guidance’s – GMP, CGMP, GAMP, 21 CFR Part 11.
  • Technical knowledge of Cleaning validation/verification, quality systems and regulatory requirements.
  • Experience in review and approval of Cleaning Validation studies.
  • Experience in review of temperature mapping studies. Ex CTU’s, Autoclaves, SIP systems.
  • A great communicator, decisive decision maker and proven ability to deliver excellence.
  • Confidence to direct off-site suppliers to the project, willingness to support the team and a laser light focus to deliver excellence
  • Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
  • Experience with new product introductions and/or process qualification/technology transfer

 

 

11153 – QC Instrumentation Specialist - Dublin

Purpose:

The role of the Instrument Specialist is to ensure the day to day running of all laboratory instruments, minimizing any downtime in the laboratory due to instrumentation issues and ensuring all equipment is installed and maintained in a validated state. The role covers Drug Substance and Drug Product instrumentation in clinical and commercial areas for ADC. The Instrumentation Specialist also has responsibilities for management of selected Analytical Instrumentation in the PDC department.

Responsibilities:

  • The Instrumentation Specialist has overall responsibility for maintaining Laboratory Instrumentation in ADC/PDC. The Instrumentation Specialist will lead troubleshooting activities and use external support as required to meet customer targets.
  • The Instrumentation Specialist is responsible for ensuring all Instrumentation activities comply with cGMP, including acting as auditee for this area. The Instrumentation Specialist assures compliance with all safety and environmental requirements. Compliance with other regulated areas such as trade compliance, human resources and spending are also responsibilities of the role for this scope of work.
  • Installs all instrumentation in accordance with company laboratory validation policies, procedures and guidelines. Reviews and approves validation activities for instrumentation.
  • Provides a preventative maintenance service to ensure functionality and a calibration service to maintain the instruments according to their working specifications. Leads shut-down PM/PV as required and ensures all contract/support personnel on site comply with site safety and GMP requirements.
  • Ensures that all instruments are maintained in a validated state through a PM/PV schedule and ensuring that this schedule is adhered to by the Instrument group and contract vendors.
  • Responsible for troubleshooting issues with all instrumentation, ensuring that incident reports are raised, investigated and closed out as required and for coordinating with vendor service engineers to come on site.
  • Ordering and installing new laboratory equipment, ensuring associated documentation is in accordance with company SDLC (System Development Life Cycle.)
  • Assumes the role of auditee where required for instrumentation and ensures timely closure of any audit observations.
  • Supports the vendor contract development and renewal business process.
  • The incumbent operates as part of self-directed team in carrying out day to day function and assigning priorities.
  • On assignment, the incumbent participates in departmental initiatives on improved compliance and quality systems.

 

 

Minimum Qualifications and Experience:

  • Supports the vendor contract development and renewal business process.
  • 5+ years’ experience.
  • Technical;
    • The Quality System.
    • Plant procedures and policies.
    • Company procedures, policies and guidelines.
    • Plant documentation.
    • Laboratory testing and documentation.
    • Validation principles and guidelines.
    • Computer skills.
    • System Development Life Cycle.
  • Communication skills both written and oral.
  • Team and interpersonal skills.
  • Technical report writing.
  • Time Management.
  • Meetings Management.
  • Analytical Problem-solving skills.
  • Planning and Scheduling.
  • Continuous improvement skills.

 

 

11075 – EHS Specialist - Carlow

Purpose:

An exceptional opportunity for an experienced Safety & Environment Specialist to join the Environmental Health & Safety (EHS) team; where they will play an integral role in developing, maintaining and continually improving the EHS systems at our world-class biotechnology facility in Carlow. They will provide technical guidance to the organisation to ensure compliance with legal requirements related to EHS as well as company’s corporate standards, policies, procedures and guidelines related to EHS and industry best practices.

Responsibilities:

  • Ensuring in conjunction with the EHS team that all health and safety regulatory requirements on the site are upheld to the highest standard.
  • Develop and implement EHS programmes in order to ensure compliance with local legislation, company standards and industry best practices. For example, programmes such as:
    • Risk assessments.
    • Contractor management.
    • Incident investigation.
    • Emergency response.
    • Chemical management.
    • Waste management.
    • Water & air management.
    • Equipment & machine safety.
    • Inductrial hygiene.
    • High risk work – e.g. hot work, confined space entry, work at height, etc.
  • Assisting operational departments in achieving and establishing compliance.
  • Demonstrating leadership and a strong desire to protect employees, our community and the environment in this world-class facility – leading with a ’safety first’ mindset.
  • Preparing reports to site, divisional and/or corporate management and regulatory agencies.
  • Evaluating all EHS applicable requirements for any new projects and processes (along with other site departments where necessary) as well as changes in the existing processes and installation.

 

Minimum Qualifications and Experience:

  • Technical primary Bachelor degree in EHS or Technical primary Bachelor degree with a post-grad EHS qualification.
  • 3+ years’ EHS experience in Pharmaceutical, or other highly regulated industry.
  • Proven track record of success in the environmental health and safety sector.
  • Experience on supporting multiple activities/projects.
  • Ability to influence others across Departments.
  • Technically strong; with understanding of a variety of EHS topics.
  • Innovative & Compliance-minded, with the drive to go seek out necessary information.
  • ‘Safety First’ mind-set.
  • Team player, capable of working within a multi functionary team environment; and to periodically lead teams.
  • Enthusiastic with a strong drive for results.
  • Self-directed, capable of using own initiative to make EHS improvements.
  • Dedicated to maintaining high standards, with the courage and candour to ensure things are done properly onsite – ‘right first time.’
  • Desire to protect employees and environment with a state-of-the-art facility.

 

10027830 – Senior QA Specialist – Finished Product - Dublin

Purpose:

The Senior QA Specialist for Finished Product/Combination products and Clinical will be responsible, with management support, for providing oversight of quality activities associated with the Finished Product Packaging Combination products and clinical activities. The incumbent will be responsible for quality oversight of the Packaging and storage of Finished Product (Combination products and clinical) completed internally at the facility. They are responsible for ensuring that testing, packaging, labelling, validation/verification and storage of company products comply with all applicable regulations. This responsibility includes the oversight of the site QMS to ensure that quality and compliance requirements are followed in line with business needs.

Responsibilities:

  • Responsible for Quality oversight, with management support of internal packaging, warehousing operations combination products, clinical, validation verification and quality control.
  • Co-ordinate the QA Finished Product team and liaise with peer internal Quality Groups to ensure on-time disposition of company Finished Product.
  • Provide Quality support to QC department to include method transfer or validation/verification activities and LIR review and approval.
  • Provide oversight to continuous quality system improvements and support implementation of improvements at the site in compliance, calibration, Preventive Maintenance, Deviation Management and the Change Control Programs.
  • Perform batch documentation review, management of changes, complaints, deviations, validations and product annual reviews related to site operations.
  • Provide QA and compliance support to projects impacting on site packaging activities.
  • Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
  • Responsible for quality review and approval of Master Packaging Batch Records in accordance with the company’s internal procedures and GMP principles.
  • Review and approval of company standard operating procedures and controlled documents.
  • Define and follow-up standard quality KPI and to review quality indicators with recommendation for actions for improvement in relation to packaging operations.

 

Minimum Qualifications and Experience:

  • Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering.)
  • Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility.
  • Minimum 3 years of experience in QA labeling and packaging/combination products and/or QC.
  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.
  • Demonstrated success records in auditing and improvement processes.
  • Ability to operate efficiently in a complex matrix organization and international environment.
  • Management skills for management of a team of experts.
  • Strong mature leadership and interpersonal influencing skills.
  • Ability to represent the company and to negotiate at different levels contacts both internally and externally.
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.
  • English fluency written and spoken (the Company language.)
  • Efficient in SAP, firstdoc. and Trackwise.

 

 

11192 – Project Manager IT - Cork

Responsibilities:

  • Reporting to the site AIT Program Lead, specifically responsible for delivery of Shop Floor Hardware and audio-visual components within the site production and support buildings.
  • The IT engineer will lead the development, of Shop Floor Hardware components such as HMI’s, OIT’s, Label Printers, Bar Code Scanners, and other hardware devices required in manufacturing or support areas.
  • Lead the development, configuration and installation of digital signage, required to display KPI’s and communication material.
  • Working with the global Unified Communication team, lead the development, configuration and installation of the AV requirements of conference/meeting rooms, IDEA centre, and common area AV needs.
  • Ensure the appropriate quality documents, such as Quality Assurance (QAPs) test plans, Quality assurance summary reports (QASR) are in place, aligned with the qualification strategy of the project.
  • The candidate will be required to work closely with team members, both global and local, responsible for the full Automation and IT scope, and with vendors / partners with responsibility for delivery of systems, on which the hardware and AV components will rely.
  • The candidate will review and ensure vendors compliance with company quality and various “playbook” standards.
  • Assess the needs of the process, applications, environment, and users, to develop a shop floor hardware infrastructure for use in a sterile manufacturing facility and supporting areas.
  • Develop SDLC deliverables, compliant with company standards, to ensure consistent implementation of hardware devices and AV components.
  • Align with the company HPV program: leverage existing hardware designs, documents & expertise where feasible.
  • Provide guidance and support to AIT team members tasked with delivery of key systems.
  • Provide input to the development of realistic project schedules and document trackers.
  • Work closely with suppliers / integrators to ensure compliance with company standards.
  • Liaise with the various stakeholders on the overall project to ensure clear communication between all parties in relation to AIT validation requirements.

 

Minimum Qualifications and Experience:

  • Relevant Computer Science or Engineering degree or equivalent.
  • Minimum of 5 years’ experience in a similar role, ideally in the Pharmaceutical industry.
  • Fluent in English, written and verbal.
  • Expert knowledge of GAMP5.
  • Strong experience in one or all the following systems: SAP, Werum PasX, OSI PI.
  • Usual place of work will be in Cork. The successful candidate may sometimes be required to attend meetings at other company sites, off-site.
  • Excellent computer skills, proficient in the use of the following Microsoft tools: Excel, SharePoint, Word and PowerPoint.
  • Strong interpersonal and communication skills (verbal and written.)

 

10025126 – QA Specialist – Dublin

Purpose:

The QA Specialist for External Quality will be responsible, with management support, for providing oversight of quality activities associated with drug substance, drug product and finished product manufacturing processes to contract manufacturing organizations. The Specialist contributes and guides the completion of milestones associated with specific projects and supports ongoing quality assurance responsibilities in support of: Contract Manufacturing oversight and quality systems including Change Control, Deviations and CAPA’s. Acts independently to determine methods and procedures on new assignments and provides guidance to lower-level personnel. Performs’ all responsibilities in accordance with company policies, procedures, and regulations.

Responsibilities:

  • Serve as Quality Assurance support and SME for Drug Substance, Drug Product and Finished product manufacturing maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing, storage and shipping activities are compliant.
  • Providing oversight of GMP systems completed by CMO’s and External Supply Chain function related to Drug Substance, Drug Product and Finished Product.
  • Provides oversight to continuous quality system improvements and supports implementing improvements at CMO’s in compliance, Preventive Maintenance, Deviation Management and Change Control Programs as they impact the company.
  • Works closely to build relationships with contract manufacturers quality personnel.
  • Works closely with internal cross-functional impacted areas, such as External Plant Operations, CMO Management, CMC/Regulatory Affairs and Technical Services to resolve open issues in a timely manner resulting from record reviews and deviation events.
  • Responsible for reviewing contractor documents i.e. Batch records, deviations and change controls to ensure that they comply with company procedures and meet company standards.
  • Approve company specific standard operating procedures and controlled documents issued by contract manufacturing organisations.
  • Support contract manufacturing organisation audits, including pre-approval inspections, as necessary.
  • Develop and issue quality metrics pertaining to the process quality activities.
  • Trends and analyses quality aspects of technical transfer activities to measure key performance indicators, identifies areas for continuous process improvements and risk mitigation, compiles and presents analyses at Quarterly Management Review meetings, proposes and leads team implementation of appropriate CAPA.
  • Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
  • Review Corrective and Preventive Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
  • Represents Quality Assurance to guide various projects and technical meetings, as needed.
  • Responsible for documenting and reporting compliance issues to management.
  • Any other duties as required by management.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree required; preference given to candidates with advanced degrees; 2 or more years cGMP experience preferred; consideration will be given to other relevant experience and education.
  • Minimum of 2-5 years’ GMP related experience in biopharmaceutical / pharmaceutical or related industry.
  • Must have experience/knowledge of drug substance, drug product and finished product manufacturing processes in a cGMP environment.
  • Must have detailed knowledge of industry best practice and current regulatory expectations concerning drug substance, drug product and finished product manufacturing.
  • Experience working with contract manufacturing organisations.
  • Ability to provide project leadership and guide successful completion of Quality projects.
  • Excellent written and verbal communication and negotiating skills.
  • Risk assessment and risk management.
  • Ability to exercise judgment with defined procedures and practices to determine appropriate action.
  • Ability to prioritize daily activities in order to meet internal and external customer needs on time of established timelines in a fast-paced environment.
  • Ability to monitor and report on assigned tasks, goals, and objectives.
  • Note: This role requires 20% travel.

 

10027666 – Quality Distribution Manager - Dublin

Purpose:

Manage site Distribution Quality Support group. Provide quality support for the company’s Global Supply Chain in Logistics, Customer Operations, and Commercial Distribution functions. Position supports the responsible persons and equivalent country quality managers in distribution related quality management systems support including but not limited to act as QA technical contact point with Country Quality Managers at affiliates, own GDP processes and procedures applicable to multiple entities/markets.

Responsibilities:

  • Own GDP processes and procedures applicable to multiple entities/markets. Collaborating with RPs and equivalent Country Quality Managers, drive continuous improvement and harmonization/optimization of processes / procedures.
  • Develop and enhance training materials related to GDP as needed.
  • Define and monitor standard quality KPI and review quality indicators with recommendation for actions for improvement. Attend and develop site Distribution related Quality Management Review meetings.
  • Collaborate with appropriate RP and Country Quality Managers to provide quality oversight for cold chain validation activities.
  • Act as QA technical contact point with Country Quality Managers at affiliates. Provide guidance, drive and monitor Quality issues related to cold chain and GDP to resolution within the company and with external parties.
  • Collaborate with APIOUC (Ireland) Responsible Person, review documentation including but not limited to Quality Agreements, change controls, deviations, validation documentation, SOPs and specifications.
  • Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
  • Support APIOUC (Ireland) Responsible Person and UK Responsible Person to ensure compliance with the general conditions of the company Wholesale Distribution Authorisations and ensure compliance with the requirements of GDP.
  • Support work streams relating to market monitoring and investigations relating to the Falsified Medicines Directive.
  • Support mergers and acquisitions by performing due diligence inspections, gap analysis and risk assessments on prospective business opportunities.
  • Support audits of contractors executed according to the company’s external audit program.
  • Project Management of Key Project Schedules across the network.
  • Demonstrates core company Values through management style.

 

Minimum Qualifications and Experience:

  • Academic degree in natural or applied sciences (pharmacy, chemistry, biotechnology, engineering.)
  • Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility.
  • Minimum 2 years of experience in QA and GDP.
  • Experience in managing contractors.
  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.
  • Demonstrated success records in improvement processes.
  • Ability to operate efficiently in a complex matrix organization and international environment.
  • Management skills for management of a team of Specialists/Sr. Specialists.
  • Strong mature leadership and interpersonal influencing skills.
  • Ability to represent the company and to negotiate at different levels contacts both internally and externally.
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.

 

2020-328 – QA Specialist - Waterford

Purpose:

Reporting directly to the Quality Assurance Team Leader, as a critical leader for the company, you will play an integral role in providing day to day Quality and compliance support to the sterile manufacturing operations.

Responsibilities:

  • Review and approval of deviation, CAPA’s, quality events and tasks.
  • Provide QA support to Change management within the Waterford Laboratories.
  • Ensure the quality system at the company is effectively implemented and maintained.
  • Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with the risk.
  • Actively contribute to continuous improvement initiatives.
  • Conduct duties in a safe manner and report all safety issues or concerns.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree in a science related subject is essential.
  • 3 years’ experience in a Quality Assurance role is preferable.
  • Operational experience of quality systems in a dynamic manufacturing environment.
  • Knowledge of requirements for cGMP, US and EU regulatory requirements.
  • Full understanding of relevant quality and compliance regulations.
  • Able to manage projects to plan/budget.
  • Effective facilitator.
  • Good communication skills at organisation, team and individual levels.
  • Understands KPI’s for the team and site.
  • Must be able to respond quickly to unplanned events, technical issues and changing needs from development programs.
  • All applicants must be open to shift work.

 

 

2020-327 – Statistician – Waterford City

Purpose:

Site SME to lead the development of site statistical systems, to lead the training of engineering and quality personnel in the use of these systems and in supporting their subsequent use on site. Enable site engineers, chemists & scientists in designing and deploying systems to transform data into useful process information. Support the expansion of current business and introduction of new drug product platforms across the site from a statistical perspective. Champion & Lead statistical best practices across the site. This is a very autonomous role that requires working with individuals/teams across all site departments on various stats related projects/investigations/continuous improvement initiatives. There is a high level of responsibility with this role, as the site SME on statistical techniques, to ensure data driven decisions are robust and can be defended in an audit scenario. Due to the site wide scope of this role, the day to day activities are very dynamic, interesting and challenging. Collaboration with the global statistics team provides a peer group to consult with on high profile topics, while offering the opportunity for development. The Statistician is an individual contributor role with no direct reporting responsibilities, but the ideal candidate must be able to lead project teams independently.

Responsibilities:

  • Provide statistical guidance for method validations and method transfers in the areas of accuracy, precision, linearity, equivalence testing (TOST,) power and sample size.
  • Support major process engineering and/or quality investigations from a statistical perspective to ensure data is available to provide focused information as part of the problem-solving processes.
  • Support the roll out of statistical process control (SPC) across the manufacturing platforms to promote equipment and product reliability.
  • Evaluate the statistical methods and procedures used to obtain data to ensure validity, applicability, efficiency, and accuracy.
  • Analyse and interpret statistical data to identify significant differences in relationships among sources of information, e.g. use statistical tools to demonstrate comparability for process transfers.
  • Develop and test experimental designs, sampling techniques, sampling plans and analytical methods.
  • Examine theories, such as those of probability and inference, to discover mathematical bases for new or improved methods of obtaining and evaluating numerical data.
  • Deliver statistical training to engineers/scientists/quality personnel, specifically in the use of Minitab and JMP statistical software.

 

Minimum Qualifications and Experience:

  • Bachelor’s, Master’s, or PhD degree in Statistics, Biostatistics, or Applied Math.
  • Minimum of 2 years prior work experience in Statistics for those with only a Bachelor’s degree.
  • In lieu of a degree in Statistics, Biostatistics, or Applied Math, individuals with 4 years prior work experience as a Statistician or Biostatistician in a related industry may also be considered for a Statistician position.
  • Excellent understanding of the applications of statistics in a manufacturing environment.
  • Experienced user of statistical analysis packages, particularly Minitab and JMP.
  • Familiar with regulatory statistical expectations.
  • Excellent problem solving and data analytical skills.
  • Strong influencing, communication and interpersonal skills.
  • Strong ability to coach and mentor others across departments.
  • Flexible with the ability to prioritise work in a dynamic environment.
  • Effective change agent and ability to manage resistance to change.

 

 

9940266 - Customer Operations Specialist (Customer Service) - Dublin

Purpose:

Specialist responsible for ensuring that the team efficiently handles customers’ enquiries such as purchase orders, vial requests, complaints for lost or damaged goods, product returns or exchanges. Work with the Customer Operations manager to ensure that training is adequate to professionally answer incoming calls and emails, understand the customers’ needs and their environment, and to improve satisfaction at sales and service support levels. Work to build strong customer relationships through proactive communication and customer facing key performance indicators plus drive regular customer business reviews. Maintain the accurate and timely processing of all orders and requests in SAP. Build excellent working relationships and regular contact with stakeholders such as Sales, Finance, Credit Management, Distribution, QA, Regulatory and Contracts. Support the Customer Ops manager in process improvements, Customer Operations specific projects and initiatives. Fully understand all of the Departmental processes and consistently seek out areas and opportunities to improve overall team efficiency in alignment with local requirements and the Customer Operations manager. Drive superior levels of compliance and efficiency with all tasks within the Dept., always ensuring every patient is treated on time every time.

Responsibilities:

  • Provide support to the Customer Operations manager in the management of the core Customer Operations tasks on a daily basis.
  • Provide regular reporting and feedback on the challenges of the day/week, and take the initiative to proactively solve issues or reach out to other Depts. for support required.
  • Provide backup and cover for the team and their customers in the case of the absence of the manager.
  • Accountable for using and maintaining established & Standardized template(s) / Document(s) / procedure(s) whenever it is applicable, in conjunction with Regional Customer Operations Snr. Manager’s guidance/recommendations and ensuring all team members are trained and compliant against same at all times.
  • Work to facilitate strong and efficient points of contact between team members and all the existing and new Customers.
  • Daily monitor and manage sales orders, rush orders, service requests and advance exchange programs with the team members (Shipping Calendar processing, etc. for both Commercial, Free of Charge/Compassionate items) Ensure all received orders are always processed by end of Business Day.
  • Support the manager to ensure Customer Business Reviews and Business Performance metrics drive best-in-class Supply Chain service to company customers.
  • Provide follow-up and solutions to customers and sales team regarding order status, product availability, shipping information, damaged or lost product. Manage the coordination of information to the customer and to the internal teams on all aspects of the order processing role. This includes all shipment status updates by Distribution.
  • Monitor closely with the Distribution team to ensure that product is delivered to the right place, at the right time and for the right patient.
  • Vaccination certificates (CoV) checking: collection, and working with medical and regulatory people in the regions in order to approve CoV, entering the information into the SAP database.
  • Ensure the follow up of the re-vaccination process by liaising with the field; make sure all information is captured.
  • New Customer Creation and modification in accordance with the appropriate control documents.
  • Ensure the highest self-adherence to all compliance requirements within the function;  Quality control – Good Distribution Practice (GDP Guidance.)
    • Data Privacy control – General Data Protection Regulation (GDPR.)
    • Financial control – Sarbannes Oxley.
    • Regulatory control – Controlled distribution.
  • Assist and execute all C.Ops activities as per SOPs for product Recalls, in close collaboration with Distribution and QA Teams.
  • Manage Customer Pre-payment processes in conjunction with current SOP and the company’s Credit Management policy. Manage: traditional and electronic Invoice Management, pre-payment and invoices not paid, late payment interest.
  • Ensure that all external inquiries from prospective and current Customers are dealt with in a timely and professional manner by the team.
  • Effectively and efficiently manage project items as assigned by the Snr. C.Ops Manager and deliver on timelines and tasks as required and in accordance with project dates.

 

 

Minimum Qualifications and Experience:

  • University Degree in Business Related or Supply Chain preferred.
  • GDP Certification.
  • Previous Pharmaceutical Experience essential, minimum of 2 years ideally in a Customer Service or Supply Chain function.
  • Fluency in English language both written and oral is a requirement.
  • Fluency in one other European language, both written and oral, is also a requirement.
  • Additional ‘other’ language skills would be desirable.
  • Strong knowledge of SAP and systems.
  • Excellent communication and relationship building skills.
  • Knowledge of Supply Chain Operations beneficial.
  • Strong computer literacy, with MS Office (Word, Excel, Outlook, Power point.)

 

 

10016773 - Supply Chain Distribution Specialist - Dublin

Purpose:

Responsible for managing and executing end-to-end Logistics processes for the shipment of products from our Manufacturing sites (internal and external) and distribution centres to the final delivery location. In this role, you should have strong logistics experience, problem-solving skills, with a high attention to detail and an excellent communicator both verbal and written with a focus on customer centricity.

Responsibilities:

  • Fully compliant with internal SOP’s, standards and associated training.
  • Coordination and execution of Product shipments across our Global Network (Primary & Secondary nodes.)
  • Manage operational logistics to ensure on-time delivery with no interruption to supply across our Global Network.
  • Support the strategic objectives of the organization focusing on optimizing the logistics network.
  • Manage aspects of the daily compliance requirement.
  • Creation of GMP and non-GMP documentation including procedures, specifications and shipping documentation across Global Logistics.
  • Responsible for CAPA’s, Change Controls & Deviations program and initiate Corrective Action plans in the company Quality Management System.
  • Coordinate introduction of new shipping lanes for new and existing products from commercial launch and clinical to commercial activities with validation SME’s.
  • Maintain regular and proactive communication with all internal and external stakeholders to ensure efficient execution of schedules.

 

 

Minimum Qualifications and Experience:

  • Degree in Business Management, Supply Chain/Logistics, or related field experience preferable.
  • At least 5 years’ working in Pharmaceutical Supply Chain Logistics or Operations role within an international environment is essential.
  • Knowledge and understanding of GMP/GDP standards.
  • SAP Knowledge of SD and MM Environment.
  • Computer literate, with MS Office (Word, Excel, Outlook.)
  • Fluency in English both written and oral is essential; fluency in other languages is desirable.

 

 

11027 - Process Engineer - Cork

Purpose:

The IPT/CoE Process Engineer will provide operational process support and expertise to the IPT/CoE to manufacture quality pharmaceutical products in accordance to meeting the company Priorities of: Compliance, Supply, Strategy and Profit Plan. The team working style is one of collaboration, coaching and facilitating to provide engineering solutions to the IPT/CoE team to support a High Performance Organisation.

Responsibilities:

  • Accountable for supporting the smooth running of the IPT value stream.
  • Responsible for actively participating in the Tier process to manage Engineering projects and proactively resolve issues before they impact the business priorities.
  • Be an active member within the cross functional IPT/CoE Team providing support, guidance and strive for Engineering excellence to ensure the success of the IPT/CoE.
  • Model the company Leadership behaviors and understand the MPS principles to drive a culture of continuous improvement building a High Performance Organisation.
  • Participate and comply with the company Quality Management System (QMS) requirements, including ownership, as relevant to you.
  • Provide ongoing coaching and support to cross functional team members, to share Engineering best practices.
  • Ensure supply of high-quality product through ensuring equipment availability, maximise performance through OEE and continuous process improvement initiatives.
  • Sound manufacturing/Engineering stewardship, equipment resource planning, maintenance scheduling and control. For example, shutdown activities, vendor management, change control.
  • Ensure highest Quality & Compliance standards.
  • Provide Engineering expertise within a wide range of projects within the IPT/CoE, such as the introduction of new equipment, improvement to the filling process etc.

 

Minimum Qualifications and Experience:

  • Appropriate 3rd level or engineering trade qualification.
  • At least three years’ experience in the Pharmaceutical industry or a similar operating environment with experience in an Engineering/Process role in a manufacturing environment.
  • Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Engineering, Manufacturing, Process etc.)
  • Knowledge of and experience in applying Lean Six Sigma and Lean methodologies and Engineering excellence through OEE, predictive maintenance planning.
  • Demonstrated leadership skills with a continuous improvement focus.
  • Project Management Experience leading projects.
  • Process and technology background: the successful candidate will understand how to drive optimization and OEE.
  • Demonstrated ability in holding project team members responsible for results and being decisive about non-performers.
  • Demonstrated ability to realize improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
  • Demonstrated high level of problem solving and facilitation skills.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Experience with Management Systems such as PM, EHS, PRINCE, Microsoft PM etc.
  • Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
  • Desirable: evidence of Continuous Professional Development.
  • Desirable: Six Sigma Yellow Belt.
  • Desirable: Project management qualification such as Project Management Professional etc.

 

 

10784 - Talent Acquisition Specialist – Carlow

Purpose:

Talent Acquisition Advisor (TAA). TAA will partner with the business to understand priority needs and will support the hiring of niche business roles specially for our Carlow site. This role will be the point of contact for all headcount reporting, and associated metrics for this area of the business from a TA perspective. The TAA will report to our Ireland Talent Acquisition Lead.

Responsibilities:

  • Supporting sourcing, advertising, mapping for niche roles.
  • Work along- side our GTA RPO recruiters and together will deliver end to end recruitment solutions for the business.
  • Understand the local market and talent supply and trends and be able to leverage external data to influence talent decisions for the business.
  • Support our early talent strategy with the assistance of our early talent specialist for Ireland. This will include but not limited to;
    • Overview of our All Ireland Intern hiring program and associated events with same.
    • Graduate hiring in conjunction with the business and other associated activities regarding Early Talent for Ireland.
  • Preparing and delivering presentations to the business.
  • Supporting all Ireland branding campaigns.
  • Representing the business at key events and fairs if and when is required.

 

Minimum Qualifications and Experience:

  • A Bachelor’s degree or CIPD qualification in a relevant discipline is required.
  • The TAA will have at least 5 years’ experience working in a large matrixed environment – manufacturing, commercial, research and agency/search organization – ideally within the pharmaceutical industry.
  • An experienced TAA with a deep understanding of direct sourcing methodologies, end to end recruitment process knowledge and competency-based interviewing skills and assessment tools is a must-have.
  • Work effectively within HR partnering with COE’s and HR Ops to deliver a holistic talent acquisition service to the business and the candidate.
  • Influential and consultative to foster strong relationship with our clients.
  • An appetite for new technology and be willing to experiment with digital and social solutions that will appeal to talent segments.
  • Thorough understanding of systems and data bases.
  • Be able to produce analytics to support robust business proposals.

 

 

9966920 – LIMS Specialist - Dublin

Purpose:

The QC gLIMS Administrator will be responsible for coordinating, facilitating, and undertaking activities pertaining to Thermo Fisher Sample Manager LIMS system (gLIMS.) The QC gLIMS Administrator will build, develop and maintain LIMS templates and be involved in troubleshooting as required. This role will support The Quality Control team.

Responsibilities:

  • Building, testing, verifying, transferring, reviewing and activation of all data required for Master Data Load in gLIMS.
  • Identify area end user requirements and enhancements to assist with Master Data Load in gLIMS.
  • Ensure the system master data is updated in a timely manner as required by the area.
  • Assist in validation (IQ, OQ, PQ) as required.
  • Author/review of validation protocols and reports to ensure compliance with current regulatory expectations.
  • Investigation of deviations and raising of change controls as required.

 

Minimum Qualifications and Experience:

  • Minimum of degree qualification in relevant science and/or IT discipline
  • 3 years in a QA/QC/Validation/IT function with strong knowledge of CSV/GAMP, 21 CFR Part 11, Project Life Cycle and cGMP Regulations governing GxP data Direct experience maintaining master data in a cGMP environment is required.
  • Good working knowledge of laboratory testing processes and automation using various instrument software packages.

 

 

2020-325 - QC & Commercial Stability Data Reviewer - Waterford City

Purpose:

To support Product Development and Commercial Supply by ensuring all components, raw materials, finished products and Stability are tested in accordance with cGxP.

Responsibilities:

  • To review raw data from testing of components/raw materials/finished products and stability in a timely & efficient manner.
  • To manage and control all raw data presented for review and file once completed.
  • To complete required release documentation including commercial stability summary sheets.
  • Trending of finished product and API testing.
  • Complete investigations in a timely and efficient manner where applicable.
  • Identify and action recommendations for improvements.
  • Implement 5S and Lean lab initiatives.
  • To support all other on-going laboratory functions & requirements.
  • To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • To perform additional team tasks as agreed to support effective running of the Business.
  • To assist in the preparation for customer/ regulatory inspections.
  • Health & Safety;
    • Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs.
    • Report any defects.
    • If unsure about safety requirements – ask.

 

Minimum Qualifications and Experience:

  • Qualified to a minimum of degree level.
  • At least two years’ experience working in a related technical environment.
  • Analytical Test Methods – Creation and Review.
  • Operation of HPLC.
  • Operation of GC, FT/IR.
  • Computer Skills/Excel etc.

 

 

2020-324 - QC & Stability Team Lead - Waterford City

Purpose:

Prioritising and coordinating the execution of QC and Stability activities in line with department and company requirements.

Responsibilities:

  • Assist the Quality Control Manager in achieving company goals.
  • Day to day scheduling of laboratory activities.
  • Management of the Raw Material testing requirements, & results reporting.
  • Using the existing laboratory tools to generate and maintain performance related metrics.
  • Coaching / Mentoring – support members of team with problem solving and skill development to aid learning and early problem resolution.
  • Recruitment – assist with recruitment of team members in line with resource requirements and to job spec.
  • Timely close out of deviations and/or investigations.
  • Assist with the timely completion of data reviewing as required.
  • To identify training requirements and training of Chemists and organize training as required.
  • To participate in all relevant training to ensure personal training plan is up to date.
  • To calibrate and check calibrations of laboratory instrumentation as required.
  • Take responsibility for issues as they arise and elevating them where necessary.
  • Timely and complete handover of documentation and work in progress.
  • Reporting on results via correct documentation in real time.
  • To draft procedures, protocols, reports and company documentation as required.
  • To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • Adhere to all good housekeeping practices.
  • Facilitate continuous improvement within the QC team.
  • Representing the Quality Control department at internal meetings and communications with customers.
  • Plan all external laboratory testing, ensuring all testing is completed on time in full.
  • Health & Safety;
    • Ensure requirements of company’s Safety Statement are implemented.
    • Continuously promote a positive safety culture by leading by example.
    • Implement safety requirements as per site documentation including SOP’s, Safety Statement and COP’s.
    • Report any defects.
    • If unsure about safety requirements – ask.
  • Recruit, train, manage and develop team.
  • To perform additional tasks as agreed to support effective running of the business.

 

Minimum Qualifications and Experience:

  • Relevant third level qualification.
  • At least 5 years previous relevant experience.
  • Analytical techniques.
  • Operation of laboratory instrumentation.
  • Computer Skills to include MS office, ECDL certification an advantage.
  • Proven time management skills.
  • People management skills.
  • Planning & organizing.
  • Multi-tasking.
  • Project management, knowledge of MS project.
  • Technical writing skills.

 

 

2020-323 - QC & Stability Chemist - Waterford City

Purpose:

To support QC and Stability by ensuring all raw materials, packaging, finished products and Stability samples are analysed in accordance with cGxP.

Responsibilities:

  • To test and complete write up of QC raw material, packaging, finished product and stability samples in a timely & efficient manner.
  • To support all other on-going laboratory functions & requirements.
  • To prepare and review stability summary sheets where required.
  • To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • Check own work and that of others for accuracy.
  • To assist in the preparation for internal / customer/ regulatory inspections.
  • Involved in internal investigations e.g. Out of Specifications, Incidents & Deviation investigations etc.
  • Draft, review or revise documentation within company documentation management system.
  • Report any Deviations/Out of Specifications to Senior Chemist and complete in a timely manner.
  • Health & Safety;
    • Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs.
    • Report any defects.

 

Minimum Qualifications and Experience:

  • Qualified to a minimum of honours degree level in Analytical Chemistry, Pharmaceutical science or related discipline.
  • At least two years’ experience working in a related technical environment is preferable but not essential.
  • Proficient in the use of HPLC & associated problem solving.
  • Proficient with Dissolution testing.
  • Strong analytical ability.
  • Quality Orientation.
  • Knowledge & proficiency of Microsoft products including, Excel, Word & Powerpoint.
  • Adaptability – maintain effectiveness in varying environments and with different tasks, responsibilities and people.
  • Broad understanding of regulatory requirements for submission of dossiers in EU, USA, Japan and other jurisdictions.
  • Analysis – secure relevant information and identify key issues and relationships from a base of information; relate and compare data from different sources, identifying cause-effect relationships.
  • Working effectively with team or those outside the formal line of authority to accomplish organisational goals; taking actions that respect the needs and contributions of others, subordinating own objectives to the objectives of the organisation.
  • Making efforts to listen and understand the customer (both internal and external); anticipating and providing solutions to customer’s needs; giving high priority to customer satisfaction.
  • Safety Awareness.

 

 

2020-322 - QA Team Lead - Waterford City

Purpose:

Reporting directly to the Quality Assurance Manager, as a critical leader, you will play an integral role within a quality team for a sterile filling facility, transforming the support provided to these functions.

Responsibilities:

  • Provide quality expertise & support to the QA team and site.
  • Implement and maintain compliant quality assurance systems on-site.
  • Leads team of Quality Assurance specialists to excellent performance through a structured quality system delivering compliance, customer service and a positive team-based work environment.
  • Oversees the day to day management of QA systems, directing the workload of the QA Specialists.
  • Provide clear open communication with the QA team and site.
  • Effective interaction with other departments or matters related to quality.
  • Ensure compliance to the Quality Management System is maintained and its effectiveness monitored.
  • Delivery of assigned projects on plan.
  • Work 12/7 shift pattern (4 days on, 4 days off.)

 

 

Minimum Qualifications and Experience:

  • Previous experience in sterile manufacturing and/or operational quality support.
  • 10 years’ experience working in a Healthcare manufacturing environment.
  • Provide ability to provide quality expertise & support to the QA team and site.
  • Proven ability to lead projects across multiple platforms.
  • Experience of managing teams would be a distinct advantage.
  • Effective technical knowledge of sterile manufacturing processes.
  • Management experience.
  • Strong manufacturing background in Quality.
  • Sterile experience highly desirable.
  • Operational experience of quality systems in a dynamic manufacturing environment
  • Detailed knowledge of quality systems.
  • Effective technical knowledge of sterile manufacturing processes.
  • Knowledge of requirements for cGMP, US and EU regulatory requirements.
  • Full understanding of relevant quality and compliance regulations.
  • Able to manage projects to plan/budget.
  • Effective facilitator.
  • Good communication skills at organisation, team and individual levels.
  • Understands KPI’s for the team and site.
  • QP eligible.

 

 

2020-321 - Maintenance Technician - Waterford City

Purpose:

As a technician you will provide leadership and support to operations teams to ensure appropriate standards are met. The role will involve the development and implementation of improvement initiatives in all manufacturing and development operations. Please note this is a shift role 24/7 (2 days/ 2 nights / 4 off.)

Responsibilities:

  • To carry out repair and Maintenance tasks of all Process and / or Facilities Equipment, to achieve an acceptable level of production output in full compliance with Quality and Safety and cGMP Standards.
  • Input of data into Maintenance PM System including the operation of such systems.
  • Working with one’s own initiative and assuming responsibility whenever the need arises.
  • May be required to train others on all equipment, Maintenance tasks, set up procedures and safety awareness.
  • To operate and maintain all equipment, to achieve an acceptable level of production output.
  • Complete all duties as per relevant Sop’s.
  • Adhere to all relevant dress requirements with respect to cGMP’s and PPE rules.
  • Conduct all maintenance duties in a safe manner and report all safety issues or concerns.
  • Maintain the required standard of housekeeping in both the maintenance workshop/facilities area.
  • Ensure all required documentation is completed accurately and on time.
  • Ensure good time keeping and attendance at place of work.
  • Support team in achieving team goals and targets.
  • Attend Team meetings as required.
  • Actively contribute to continuous improvements across the plant.
  • Support and back up of all maintenance teams i.e. facilities and manufacturing when required.
  • Ensure correct and accurate communication of equipment issues/PMs/repairs including reporting of serious downtime (via email.)

 

 

Minimum Qualifications and Experience:

  • Junior & Senior Trade’s Certificate or an equivalent third level qualification.
  • At least 5 years’ Experience working as a Maintenance Technician in a Multi-skilled Team environment.
  • 2 years’ experience working as a Maintenance Technician in a pharmaceutical-manufacturing environment.

 

 

2020-320 - Junior Process Engineer - Clonmel

Purpose:

Reporting directly to the Operations Team Management, the role will support and actively participate in the delivery of Production and Engineering objectives, with particular focus on process and quality improvements.

Responsibilities:

  • Support the development and implementation of projects while maintaining safety, environmental and company standards and procedures.
  • Manage and report on specific projects and investigations as part of the overall Operations Excellence project.
  • Analytics of Key process variables and reporting on same.
  • Develop & promote solution-based protocols arising from manufacturing issues.
  • Support the commissioning stage of projects and process upgrades.
  • Further actions in planning of 3-year safety plan and Operations Excellence plan.

 

 

Minimum Qualifications and Experience:

  • HETAC Level 8 Degree in engineering discipline, or similar with relevant experience.
  • Experience with the use of lean manufacturing tools.
  • Excellent interpersonal skills in directing and influencing teams and building strong collaborations.
  • Possess an understanding of a manufacturing environment and process led activities.
  • High energy and commitment to Best Practice and Continuous Improvement.
  • Self-motivated and enthusiastic.

 

 

2020-319 - Project Engineer - Clonmel

Purpose:

This person will be part of engineering team tasked with delivering large capital program. They will be responsible for initial stakeholder consultation, project scoping, initial engineering, procurement, day to day project management and safe handover of project upon completion. The person should be able to communicate project information effectively with all stakeholders.

Responsibilities:

  • Ensure projects are compliant with all relevant health, safety, environmental, quality standards and procurement policy.
  • Lead key improvement projects.
  • Provide innovative solutions, pre-engineering activities and project cost estimates for Strategic and Capital projects.
  • Develop tender documents for Projects.
  • Direct and manage all stages of each project from planning to completion throughout the project lifecycle.
  • Draft and submit budget proposals, deliver progress reports and manage project resource allocations.
  • Provide leadership and direction to project teams and technical assistance to operations & maintenance teams as required.
  • Manage day-to-day operational aspects of a project. Ensure project documents are complete, current, and stored appropriately.
  • Ensure proper handover to operations on completion including key aspects of safety, training & communication.
  • Determine compliance position in aspects of ATEX, Dust, Pressure vessels, Fire protection and Asset condition outlining path to modernization.

 

Minimum Qualifications and Experience:

  • BEng Degree in Electrical/Mechanical Engineering or alternative Engineering discipline.
  • 3+ years relevant experience in a project management /engineering capacity in large manufacturing/industrial setting. Electrical experience advantageous.
  • Competent working knowledge of project management systems and software.
  • PLC/NETWORKING/HT experience advantageous.
  • CAD/Drafting/Modelling advantageous.
  • Ability to effectively prioritize and execute tasks within time constraints.
  • Basic financial skills.
  • High level of motivation and commitment to best practice and continuous improvement.

 

 

2020-318 - Technical and Process Specialist - Clonmel

Purpose:

The Technical and Process Specialist will provide scientific and technical support of engineered wood panel manufacture through all stages of the product life cycle, from technology transfer, process validation, manufacturing support, continuous improvement programs.

Responsibilities:

  • Implement strategic process and product development objectives and plans through innovation and PMF models.
  • Support and actively contribute to technical & development initiatives while complying with all relevant regulatory, safety, technical and quality standards.
  • Contribute to operational excellence for process and quality improvement.
  • Contribute to a quality and customer focused innovative culture within the company.
  • Be able to plan and execute measurable commercial, and technology transfer projects.
  • In conjunction with the operating area develops operating procedures, SOPs and start up documentation.
  • Develop strong working relationships both internally across department and externally with industrial partners.

 

Minimum Qualifications and Experience:

  • Relevant HETAC level 8 in Science with a bias towards Chemistry or Chemical Engineering.
  • Minimum two years’ experience in industry.
  • Good knowledge on GMP, Lean Principles, analytical methods.
  • Excellent communication, research and presentation skills required.
  • Attention to detail in compliance with product certification and standards.
  • Strong teamwork with the ability to relate to people across a wide range of operational levels.
  • Creative thinker and be able to work under own initiative.

 

 

9741959 – Senior QA Specialist – Dublin

Purpose:

The Senior QA Specialist for the Bulk Drug Substance (BDS) facility will be responsible, with management support, for providing oversight of quality activities associated with the manufacturing and disposition of bulk drug substances. They are responsible for ensuring that manufacturing, testing, labeling, and storage of Bulk Drug Substances comply with all applicable regulations. This responsibility includes the oversight of the site QMS to ensure that quality and compliance requirements are followed in line with business needs. The Senior QA Specialist executes the site QA activities at the company in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets. This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Operations, QC, QPs, Facilities, Engineering and Supply Chain to optimize patient supply.

Responsibilities:

  • Provide quality and cGMP input and oversight for all NPI project activities through commercial readiness for the facility.
  • Review and approval technical support documentation. (Examples include cleaning, process, method validation.)
  • Review and approval of functional area documentation (SOPs, Work Instructions, technical reports and protocols.)
  • Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.
  • Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
  • Responsible for review and approval of Master Batch Records in accordance with the company’s internal procedures and GMP principles.
  • Responsible for review and approval of Master electronic Batch Record recipes in accordance with the company’s internal procedures and GMP principles.
  • Provide oversight of quality management system activities including Preventive Maintenance, Deviation Management and the Change Control Programs.
  • Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
  • Author, review and approve Quality Related Procedures as required.
  • Support the Vendor Management Program.
  • Support the Raw Material Qualification Program.
  • Develop and report quality metrics.

 

 

Minimum Qualifications and Experience:

  • Academic degree in natural or applied sciences (Pharmacy, biology, biotechnology, engineering.)
  • Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility.
  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.
  • Demonstrated success records in auditing and improvement processes.
  • Ability to operate efficiently in a complex matrix organization and international environment.
  • Strong mature leadership and interpersonal influencing skills.
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.
  • English fluency written and spoken (the Company language.)
  • Efficient in SAP, EMDS, MES and Trackwise.

 

 

10584 - Project Engineer - Cork

Purpose:

The role of the Project Engineer is to support Fire and Safety Systems function in the facility on behalf of the Engineering Department. The successful candidate will be responsible for ensuring there is a strong safety culture and performance in the management of life safety systems. The Fire Safety Project Engineer will report to the company Fire & Safety System Specialist through COE Engineering group.

Responsibilities:

  • Project management of both fire and life safety system improvements driven by continuous improvement, loss prevention recommendations or business needs.
  • Support Fire and Safety Technical Specialist with the execution of fire evacuation drills.
  • Support Fire and Safety Technical Specialist with fire and safety incidents and corrective actions relating to fire safety systems. This will require sound problem-solving skills and methodology.
  • Support change management of fire and safety systems through “Management of change” process as change initiator or approver.
  • Support the closure of planned maintenance works and ensure all unplanned works/ recommendations are assessed and closed appropriately.
  • Set up new Fire and safety equipment on maintenance system and implement maintenance routines to ensure high maintenance levels for new building start-ups.
  • Support fire safety and egress standard compliance with the completion of building walk downs and completion of emergency egress assessment, highlight actions and review until closure.
  • Compile and manage monthly fire and life safety and alarm metrics for forum discussion.
  • Review and assess High Risk Work activity permitted works ensure emergency response plan meets company Safety Standards.
  • Complete GEMBA walkdown with areas owners through leadership standard work process ensuring area, procedures and documentation is aligned with company Quality and Safety standards.
  • Have the capability to prioritise workload to meet site business requirements.
  • Manage costs by forecasting and monitoring spend on Fire/Safety system budgets.
  • Create Snag lists and ensure Projects are completed to a high standard of Quality.
  • Use Lean principles across all technical aspects of the process, by deploying company Six Sigma tools. Responsible for driving a culture of Compliance and delivery on time.

 

Minimum Qualifications and Experience:

  • Degree or 3rd Level Qualification (Engineering.)
  • Desirable to have qualification in Project Management.
  • 5+ Yrs. working in a similar role with relevant experience in the project management of capital projects in a high-tech industry, preferably in Pharma/Bio Pharma. Experience in Fire and Safety systems management would be an advantage.
  • Desirable evidence of Continuous Professional Development
  • Must have a thorough understanding and application of engineering principles, concepts, industry practices and standards.
  • Proven track record in delivering Projects.
  • Must have meticulous planning and strong communication skills.
  • Ability to work on own initiative to resolve issues.
  • Demonstrated high level of problem-solving skills.
  • Advanced PC skills such as Excel, Word, PowerPoint, MS Project or Primavera (SAP, MIDAS, TRACKWISE and SharePoint use experience also an advantage.)
  • High level of knowledge of Safety, Quality and Environmental requirements.
  • Excellent verbal and written communication skills/presentation skills.
  • Ability to plan, prioritise and effectively manage time, meet deadlines and produce quality deliverables.
  • Proven knowledge, appreciation and experience of working in strongly regulated GMP environment.
  • Understands the typical project life cycle from concept through to qualification and has proven experience in this area.
  • Demonstrated successes in a team environment, such as project teams.

 

 

10573 - Process Engineer - Tipperary

Purpose:

Our Formulation R&D facility is the first purpose-built facility supporting oral solid dosage commercialisation within the company network. Within this facility new drug product processes are developed, scaled up and optimised using cutting edge manufacturing technology to provide product for clinical trials and commercial supply. This position is for an Associate Specialist MES Engineer in the technical area of the formulation facility.

Responsibilities:

  • Working in conjunction with Process Engineers, Perform MBR authoring and MBR updates in Werum Paz X for new and existing OSD processes.
  • Providing strong MES/Werum Pax-X support to production teams including support to daily operations, problem solving/issue resolution and driving continuous improvement.
  • Develop/create MBR design elements (building blocks) and workflows in Werum PAS-X.
  • Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems.
  • Documentation of all activities in line with cGMP requirements.

 

Minimum Qualifications and Experience:

  • Bachelors or postgraduate degree in Engineering or a Science related discipline.
  • Ideal candidate will have minimum of 2 years relevant experience in Oral Solid Dosage.
  • 2+ years of hands-on experience on MES Product, MBR design & Werum PAS-X product.
  • Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry is required.
  • Ability to work independently as well as in a team environment.
  • Strong MES/IT applications aptitude.
  • Have Strong communication skills and technical writing skills.
  • Have strong problem-solving skills.
  • Excellent Working knowledge of MES, in particular Werum PAS-X.
  • Working knowledge of SAP would be beneficial.

 

 

10555 - Automation Engineer - Tipperary

Responsibilities:

  • Development of Process Control Applications on DCS, PLC and BMS platforms.
  • Identify, evaluate & implement opportunities for continuous improvement.
  • Provide day to day support to Operating Areas for Automation components of the process.
  • Proactively resolve technical issues before they impact the business priorities.
  • Support the smooth running of the site value stream and supply by delivering a world-class Automation service.
  • Ensure adherence with standards, following business processes in the execution and support of Automation systems.
  • Comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Work collaboratively to drive a safe and compliant culture Core Competencies Technical.
  • Computer System Development Lifecycle.
  • DCS Systems.
  • PLC – Siemens TIA Portal, Siemens S7, Allen Bradley.
  • SCADA – Siemens WinCC, Wonderware, Allen Bradley Factorytalk.
  • Data Historians.
  • BMS Systems – Siemens Desigo.
  • Control System/Shopfloor Integration.
  • System Virtualisation.

 

Minimum Qualifications and Experience:

  • Degree Qualification ideally in a related Automation, Engineering, Computer or other Technical Discipline.
  • 5+ years experience.
  • Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment.
  • Proficiency in Microsoft Office and job related computer applications required.

 

 

2020-312 - QC Chemist - Waterford City

Purpose:

You will contribute to the continued success of our QC department by providing analytical services to support our diverse manufacturing operations. Engage with our Continuous Improvement programme to share your ideas and experience to further optimise our laboratory function. Comply with all regulatory and safety guidelines to protect yourself, your colleagues and our patients.

Responsibilities:

  • Provide analytical chemistry services and support to Site.
  • Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases. In particular, close contact maintained with Quality Assurance Production, Engineering and Planners.
  • Maintain, update and issue chemical methods, specifications and SOP’s in compliance to pharmacopoeial and regulatory requirements.
  • Assist with training of the analysts in areas of expertise and knowledge and in new methods, SOP’s and updates.
  • Trend such results, record on COA’s where required and complete OOS’s investigations on a timely basis.
  • Support new product introduction projects.

 

Minimum Qualifications and Experience:

  • Degree in Science (Chemistry or Biochemistry preferred.) Post-graduate studies as appropriate to augment primary degree.
  • Operational experience of quality laboratories in a fast moving manufacturing environment.
  • Detailed knowledge of quality management systems, pharmaceutical manufacturing operations, requirements for cGLP, pharmacopoeial methods and stability.
  • Understand relevant quality/compliance regulations.
  • Can manage projects to plan/budget.

 

 

9741959 - Senior QA Specialist - Dublin

Purpose:

The Senior QA Specialist for the Bulk Drug Substance (BDS) facility will be responsible, with management support, for providing oversight of quality activities associated with the manufacturing and disposition of bulk drug substances. They are responsible for ensuring that manufacturing, testing, labeling, and storage of Bulk Drug Substances comply with all applicable regulations. This responsibility includes the oversight of the College Park QMS to ensure that quality and compliance requirements are followed in line with business needs. The Senior QA Specialist executes the site QA activities in order to protect the safety, quality and efficacy of our products, thereby ensuring the availability of correct, safe product for our Patients, and assuring the security of the company’s business and global markets. This key role must ensure effective interaction with other departments and locations regarding GMP Document review and finished product releases. In particular, this will involve partnering with major stakeholders such as Operations, QC, QPs, Facilities, Engineering and Supply Chain to optimize patient supply.

Responsibilities:

  • Provide quality and cGMP input and oversight for all NPI project activities through commercial readiness for the facility.
  • Review and approval technical support documentation. (Examples include cleaning, process, method validation.)
  • Review and approval of functional area documentation (SOPs, Work Instructions, technical reports and protocols.)
  • Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/ controlled.
  • Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow up actions.
  • Responsible for review and approval of Master Batch Records in accordance with company internal procedures and GMP principles.
  • Responsible for review and approval of Master electronic Batch Record recipes in accordance with company internal procedures and GMP principles.
  • Provide oversight of quality management system activities including Preventive Maintenance, Deviation Management and the Change Control Programs.
  • Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
  • Author, review and approve Quality Related Procedures as required.
  • Support the Vendor Management Program.
  • Support the Raw Material Qualification Program.
  • Develop and report quality metrics.

 

 

Minimum Qualifications and Experience:

  • Academic degree in natural or applied sciences (pharmacy, biology, biotechnology, engineering.)
  • Minimum 5 years in international pharmaceutical and/or biotech industry with increased level of responsibility.
  • Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.
  • Demonstrated success records in auditing and improvement processes.
  • Ability to operate efficiently in a complex matrix organization and international environment.
  • Strong mature leadership and interpersonal influencing skills.
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels.
  • English fluency written and spoken (the company language.)
  • Efficient in SAP, EMDS, MES and Trackwise.

 

 

 

10424 - Drafter - Cork

Purpose:

This role will be to provide support to the existing Cork Drawing Office and Engineering Project teams in the preparation of CAD drawings. As an integral part of a design team you will be responsible for developing new drawings, amending existing drawings to reflect as built conditions in the field. Candidates should be motivated and enthusiastic, have the ability to work on their own initiative and be able to meet deadlines and liaise successfully with clients.

Responsibilities:

  • Produce and amend drawings in line with the site Drawing Management System.
  • Participate in all activities within the drawing office. Ensure that all architectural, electrical, mechanical, civil, instrumentation, general layout drawings are at the correct revision.
  • Ensure that all change management updates are captured and reflected on the appropriate drawings.
  • Ensure that drawing documentation packages issued from projects are correct and are in line with site standards.
  • Ensure compliance for all drawings and procedures that fall under the responsibility of the company.
  • Assist with the development of draughting and documentation staff as required.
  • Ensure all drawings are stored correctly in electronic and paper format and that all drawings issued and received by the department.
  • Carrying as built surveys of existing P&ID drawings and ensure current drawings reflect the as built site conditions.
  • Work closely with the Drawing Office Manager and Engineering Project Teams to develop solutions.
  • Ensure all activities are carried out in line with Company QA & EHS Requirements and Procedures. Play an active role in the CAD Standards/Standard Operating Procedures input.

 

Minimum Qualifications and Experience:

  • Minimum of Higher National Diploma or Higher National Certificate qualification in Engineering.
  • 5+ Yrs Industry Experience with 3+ Yrs working in a similar role.
  • Minimum of 5 Yrs Experience with using AutoCad.
  • Good Written and verbal communication skills.
  • Interact with above site personnel to understand changes and promote the site.
  • Solid engineering acumen.
  • Demonstrated capability to communicate effectively across multiple teams.
  • Good knowledge of GMP / FDA regulatory requirements and current Health and Safety Regulations legislation.
  • Excellent presentation and written / verbal communication skills.
  • Team player, with a flexible approach.
  • Ability to work autonomously.
  • High Attention to detail and accuracy.
  • Experience with 3D modelling software packages would be an advantage.
  • The ability to meet deadlines.

 

10339 - Process Engineer - Carlow

Purpose:

As part of this Technical Transfer Lead role you will be responsible for the transfer of a syringe product from the existing line to the newly expanded facility, and a formulation process from a US site to Carlow. As part of your role you will be leading a technical team to ensure that all aspects of the technical transfer process will be adhered to. As part of this role you will be the key point of contact on site for all aspects of the technical transfer which will require liaising with internal and external stakeholders. The role will be required for Q1 ’20 to help form the teams and build the technical transfer plan for the product. This will also ensure that process requirements will be embedded during the construction phase of the project (equipment and facility). Ultimately the Product and Process Qualification batches are planned mid 2022 with regulatory approval in 2023. Within this role you will be acting as the technical transfer lead for the syringe product, reporting within the Technical Engineering department.

Responsibilities:

  • Lead and execute process engineering activities to support the technical transfer of products to site. This includes but is not limited to: cycle development, Equipment PQ, PPQ’s, Cleaning, PCM, CTU mapping, filter validation, etc.
  • Plan, schedule and resource the complete technical transfer programme and then to lead the team to successful completion of the product introduction to regulatory approval and initiation of commercial production.
  • Engage in the early stages of the project, giving input into design by working with equipment vendors and global engineering teams to ensure that the process and product requirements are met.
  • Providing technical and product oversight to the process, design and project delivery teams and coaching to associate staff within the assigned suite.
  • You and your team will be required to Author and review procedures and technical reports required as part of the technical transfer.
  • You and your team will be Technical review and approval of Validation protocols executed by vendors, cross functional groups and/ or validation counterparts.
  • Supporting regulatory submissions, in particular driving the post approval change management process being adopted for this product.
  • Owning Change Management process for the product introduction.
  • Effective application of LeanSixSigma and Change Management tools by:
    • Leading by example in achieving results by using industry standard tools and processes.
    • Facilitate problem solving & risk assessment (FMEA) projects/meeting.
    • Make problems visible and strive for continuous improvement.
    • Serving as a key member during internal audits and external inspections/audits.
    • Supporting alignment and knowledge exchange with development organizations, other commercial nodes and external manufacturing partners.
  • Lead and support various organizational initiatives as needed (examples include EHS, workload forecasting, work standardization, etc.)
  • Represent the site in internal collaborations through Manufacturing Division Validation Communities of Practice to include sharing of best practices.
  • Keep up to date with scientific and technical developments, best practices and attend seminars as required.
  • Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

 

Minimum Qualifications and Experience:

  • Minimum of 10 years directly related experience in academia, pharmaceutical or biotechnology industry.
  • A working knowledge of current regulatory requirements and current Good Manufacturing Practices.
  • The successful candidate will also have demonstrated the ability to deliver what is needed on-time, holding self and team members accountable for commitments, decisions, actions and behaviours.
  • Excellent oral and written communication skills.
  • Ability to effectively articulate understanding of process science, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
  • Show ambition and drive to develop and advance within the role.
  • Process or technical transfer experience on Large Scale Projects.
  • Leadership experience managing a team to deliver short and long term objectives as part of a project or program.
  • Project Management experience / training in use of Project Management tools.
  • SME on Equipment within a sterile fill finish environment; e.g. CIP & Parts Washer / SIP / Autoclaves / DHT & Electron Beam sterilisation / Vaporised Hydrogen Peroxide Sterilising Isolators / Clean Utilities Transfer Panels & Formulation Vessels.
  • Working knowledge of ASTM E2500 / Eudralex / FDA / ISPE guidelines.
  • Experience with liaising with other departments – engineering, technical, operations, QA and Regulatory Affairs.
  • Experience with sterile processing and sterilisation technologies.
  • Experience with cleaning and process validation, technology transfer, regulatory filing, and commercial drug product manufacturing of biologics is a plus.
  • Prior experience in drug product processing equipment, PQ, Process Performance Qualification and Validation, site readiness, batch record reviews, authoring documents subject to regulatory inspection.
  • Desirable but not essential;
    • Visual Inspection technologies for Vial / Syringe.
    • Vial / Syringe processing technologies; drug product filling, glass handling, tray handling, stoppering, capping and CCI.
    • New facility brown/ green field facility experience.
    • Small equipment qualification and validation; FITs, Scales, Tube Sealers/ Welders, Headspace analysers, Flowmeters, Mobile Vessels & Single Use Technologies.

 

2020-306 - Engineering Project Manager - Waterford City

Purpose:

This is an opportunity to manage engineering projects and lead engineers while introducing new medical device manufacturing systems and delivering product, cost and quality improvements in a fast-paced environment.

Responsibilities:

  • Create and manage project schedules and budgets.
  • Communicate project information to all stakeholders (across many sites.)
  • Identify, quantify and justify improvement opportunities.
  • Develop requirements documentation for equipment and machine controls software systems.
  • Develop and implement new technologies and systems to support R&D projects.
  • Demonstrate leadership skills to engage team members.
  • Demonstrate team building skills with motivated team members working well together.
  • The role will require travel to the USA and central Europe as project mix varies.

 

Minimum Qualifications and Experience:

  • Bachelor level degree in Engineering or other relevant technical equivalent. Master’s level qualification advantageous.
  • 5-7 years’ experience of project execution and supervision of engineers.
  • Experience with medical device and/or pharmaceutical production required (cGMP / FDA regulated environment.)
  • Knowledge of some of the following: software development life-cycle, GAMP V, SPC, DOE, Statistical Analysis, and Project Management (PMI certification a plus.)
  • Project Management of high volume, low-cost manufacturing systems (may include pneumatics, PLCs, motion control, robotics, HMIs and SCADA.)
  • Capable to lead, motivate engineers and others in project execution.
  • Self-directed. Excellent communication skills.
  • Ability to form relationships with stakeholders from many sites and work within cross functional teams.

 

10264 - Scientific Technical Specialist - Cork

Purpose:

This position will provide technical and validation support to the Vaccine IPT to support the manufacturing and validation of processes for Vaccine IPT to meet the company priorities of: Compliance, Supply, HPO, Strategy and Profit Plan. The Technical Specialist will be required to collaborate and facilitate running of activities (PPQ batch manufacture, validation activities, cleaning validation, requalification, periodic monitoring, investigations, change control) in the Vaccine IPT to ensure the effective and efficient on-time delivery of these activities for the Vaccine IPT. This requires the delivery of technical excellence to deliver components of a stable process, supported by a flexible, collaborative, multi-skilled teamwork environment.

Responsibilities:

  • Ensure the highest Quality, Compliance and Safety standards primarily not only with technical and validation activities but relating to all activities.
  • Work within a team to enable the team’s performance in the Vaccine Technical group within the Vaccine IPT.
  • The Technical Specialist will participate and comply with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant to you.
  • Provide technical stewardship, equipment resource planning and validation schedules.
  • Responsible for the technical support of manufacture in the Vaccine IPT.
  • Input into technical and validation planning and decisions for the Vaccine IPT, to ensure supply of high-quality product through tactical planning and execution of production schedules.
  • Lead and close process qualification and validation related deviations and reports and participate in problem solving teams across all areas of the Vaccine IPT (e.g. reliability, Safety, Quality (e.g. CAPA/QNs etc.)
  • Protocol/report authoring/execution/oversight/approval as appropriate.
  • Technical review, ownership of and approval of Global Change Management records as required.
  • Cleaning validation activities, Periodic reviews, Requalification of equipment.
  • Recommend technical approaches in line with global and local standards.
  • Contribute for driving a culture of Continuous Improvement by deploying company Six Sigma tools and MPS within the IPT on projects such as: problem solving, reducing cycle time, lean principles within the new processes.
  • Stakeholder management of multiple decision makers, corporate colleagues, cross-functional team by demonstrating the ability to maintain and strengthen trust relationships with people on all levels.
  • Participate and comply with the company Quality Management System (QMS) requirements, including ownership, as relevant.

 

 

Minimum Qualifications and Experience:

  • Degree or Masters in a Science or Engineering discipline (preferably Biotechnology.)
  • 3 years’ experience in biopharmaceutical/vaccines environment.
  • Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations / validation. Experience of involvement in a technical project is an advantage.
  • Knowledge of regulations and applicable standards for quality, safety, regulatory within the biopharmaceutical/vaccine area.
  • Audit experience.
  • Experience in Validation activities e.g. Cleaning Validation, Requalification.
  • Experience Data Integrity would be an advantage.
  • Preference for Lean Six Sigma qualification or experience of application of Lean principles.
  • Project management qualification such as, Project Management Professional is desirable.
  • Evidence of Continuous Professional Development.
  • Demonstrated knowledge in more than one pharmaceutical or Biopharmaceutical manufacturing operation (e.g. manufacturing, technology, validation, engineering, quality.)
  • Demonstrated ability in holding project team members responsible for results and being decisive about non-performers.
  • Demonstrated ability to realize improvement initiatives.
  • Demonstrated successes in a team environment, such as project teams, Six Sigma team.
  • Demonstrated high level of problem solving and facilitation skills.
  • Advanced PC skills such as Excel, Word, PowerPoint.
  • Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
  • Experience in an FDA / HPRA Regulated production environment.

 

Associate Director (MPS) - Leinster

Purpose:

As part of the Manufacturing Division, the Manufacturing Systems Design & Commercialization Team is responsible for installing MPS for the new company site. MPS will be embedded into the foundation at start up and become the basis for how we operate. The focus will be on the design and execution of the operating systems, management systems, mindset and behaviors, and capabilities of our people enabling us to produce critical vaccines and biologics medicines at the highest quality, for the lowest cost, and in the shortest lead time. The MPS associate director will work with the IPT leaders and site MPS to design, build and qualify lean systems and processes that directly support manufacturing. Significant time will be spent on the shop floor providing direct, hands on support of activities, with the expectation of coaching leaders and developing MPS capabilities within the organization, implementing local standards used for commercialization and launch activity.

 

Responsibilities:

  • Sponsor and drive a safe-by-choice culture to achieve Target Zero for workplace injuries.
  • Partner with and consult cross-functional groups, plant manager and the leadership team to develop plans and execute lean design for this new facility operations and infrastructure.
  • Develop and install lean management systems and processes for the shop floor through the use of visual factory and Leaders Standardized Work.
  • Build MPS capabilities by executing people development plans and processes.
  • Utilize various lean tools, techniques and global standards to design and install critical business processes and standardized work.
  • Provide teaching and coaching to effectively transfer Lean skills into the organization for the development of Lean Leaders.
  • Sponsor and drive company-owned sustainability goals and actions.

 

 

Minimum Qualifications and Experience:

  • Sponsor and drive a safe-by-choice culture to achieve Target Zero for workplace injuries.
  • Partner with and consult cross-functional groups, plant manager and the leadership team to develop plans and execute lean design for this new facility operations and infrastructure.
  • Develop and install lean management systems and processes for the shop floor through the use of visual factory and Leaders Standardized Work.
  • Build MPS capabilities by executing people development plans and processes.
  • Utilize various lean tools, techniques and global standards to design and install critical business processes and standardized work.
  • Provide teaching and coaching to effectively transfer Lean skills into the organization for the development of Lean Leaders.
  • Sponsor and drive company-owned sustainability goals and actions.

 

 

Senior Microbiologist - Cork

Purpose:

This position requires someone with strong Microbiology experience to provide multidisciplinary expertise and technical support to the Analytical Sciences team and commercial testing laboratories.

 

Responsibilities:

  • Responsible for leading the effective and efficient running of Microbiology Projects both globally and locally, Analytical Method Transfers, Validations, Verifications, Investigations and Change Control.
  • The successful candidate will be a member of the Analytical Sciences Leadership team governing the Analytic Sciences group.
  • Required to demonstrate a high level of technical leadership, collaboration, and coaching to facilitate the team in becoming a high performance organisation and ensuring timely delivery of projects.
  • Active engagement and communication with all internal and external stakeholders.
  • Deliver technical excellence for analytical method stabilisation and process optimisation studies which will deliver and maintain process robustness.
  • Support assay optimisation/investigations within the Microbiology area.
  • Technology Transfer – Preparation of documentation associated with the projects in accordance with GDP (good documentation practice) and site procedures.
  • Lead the delivery of projects whilst adhering to project timelines through the use of project management tools.
  • Lead cross-functional problem-solving teams for troubleshooting, and investigations within local Quality, other our company Sites and contract laboratories as required.
  • Commissioning and Qualification of various lab equipment and design and execution of assay and equipment validation studies and ongoing monitoring.
  • Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc.
  • Actively pursue development opportunities to increase the skill set and experience within the group through continuous education, job rotation, cross-functional training, Lean Six Sigma, etc.
  • Collaborate with internal partners (i.e. other sites, R&D) and externally with CROs.

 

 

Minimum Qualifications and Experience:

  • BSc in a relevant Science discipline.
  • Good knowledge of working practices required for working in a Microbiology laboratory (e.g. Bioburden, Endotoxin, Sterility testing etc.)
  • Experience with leading analytical method validations/Verifications.
  • Self-motivated and ability to work as part of a team with good project management skills.
  • High level written and verbal communications with advanced PC skills.
  • Knowledge and experience of operating in a development and commercial lab environment.
  • Desired Qualifications/Experience:
  • D./M.Sc. qualification (Science.)
  • Knowledge of and experience in applying Six Sigma and Lean methodologies.
  • Equipment commissioning and qualification.

 

 

2019-298 - Process Engineer - Waterford City

Responsibilities:

  • Liaise with external and internal customers, suppliers and agencies to define and improve manufacturing and development operations.
  • Optimisation of manufacturing and development operations.
  • Identification & implementation of opportunities for improvements.
  • Assist in the implementation of capital projects.
  • Act as process lead for inspection development.
  • Lead technical problem resolution & RCA for all manufacturing operations, in conjunction with cross functional teams.
  • Implementation and monitoring of performance metrics.
  • Lead cycle time reduction initiatives in conjunction with manufacturing teams.
  • Implementation of best practice.
  • Process development programme design / plant trials, execution and implementation.
  • Constantly seeking to challenge operational standards and driving continuous improvement.

 

Minimum Qualifications and Experience:

  • Degree in Chemical, Industrial or equivalent Engineering discipline.
  • Minimum 5 years’ experience in an Engineering role.
  • 1 – 2 years’ experience of sterile pharmaceutical manufacturing environment.
  • Technical knowledge of relevant manufacturing technology.
  • Detailed knowledge of cGMP.

 

 

2019-297 - Senior Microbiologist - Waterford City

Purpose:

This role serves both Quality Control and Quality Assurance functions. The primary responsibility will be in the microbiology laboratory sampling, testing and reporting data. QA activities will involve administration end execution of internal control systems such as line clearances, internal audits etc. Also included in the role is responsibility for development and management of QA systems.

 

Responsibilities:

  • Analysis of raw material, in process material and finished products as required.
  • Sampling of materials, utilities and environment.
  • Analysis of utilities and services i.e. water, air, environmental.
  • Participate in method transfer, method development and validation s as required.
  • Ensure that all testing equipment is cleaned, set-up and operated according to Standard Operating Procedures.
  • Perform on-line machine adjustment and trouble-shooting where necessary.
  • Review and assess results and action appropriately e.g. OOS, material Status, deviations, alarms etc.
  • Managing consumables supply within the laboratory.
  • QA Responsibilities:
    • Development, maintenance and implementation of Quality Assurance system to ensure compliance with relevant regulatory requirements. Systems include:
    • In house auditing.
    • Exception and deviation management e.g. CAPA, Non-Conformance etc.
    • Documentation review including Batch records.
    • Supporting quality aspects of materials management including line clearance, supplier approval, supplier complaints, and specification management.

 

Minimum Qualifications and Experience:

  • Qualification in science discipline at primary degree or diploma level. The Qualification must have a high microbiological content.
  • Experience in endotoxin analysis, bioburden analysis, and sterility would be an advantage. Basic techniques e.g. culture transfer, growth promotion are required.
  • Experience in Method validation and method transfer would be an advantage.
  • Aptitude for and/or experience with computer literacy would be an advantage.
  • Experience of scientific report writing including such documents as SOP’s, protocols, deviations, reports etc.
  • Ability to evaluate and access information to determine appropriate risk and required actions is critical.
  • Understanding of pharmacopeia requirements for pharmaceuticals.

 

Clinical Affairs Manager (Veterinary) - Waterford City

Purpose:

To support the Head of Scientific Affairs with clinical activities associated with the registration of company Veterinary products in Worldwide markets with emphasis on US and EU. Manage activities associated with Veterinary Clinical Trials including Target Animal Safety studies, and Efficacy studies for Veterinary projects. To ensure that project plans and milestones are delivered according to agreed timelines.

 

Responsibilities:

  • Project Planning/Co-ordination –
    • Together with the Head of Scientific Affairs and in collaboration with the Regulatory Affairs Manager, actively plan the Veterinary Clinical function requirements ensuring major milestone targets for each product are visible to all team members and key stakeholders to achieve on time market entry.
    • Together with the Head of Scientific Affairs and in collaboration with the Regulatory Affairs Manager, determine tasks and resources required to deliver each project milestone and deliverable.

    Clinical Studies –

    • Design and manage all clinical trials associated with the Veterinary projects including target animal safety and efficacy studies in collaboration with external experts and Clinical Research Organisations.
    • Identify and manage external resources required to ensure completion of the necessary studies to achieve the target milestones. Travel to clinical sites may be required to ensure Sponsor oversight of the studies

    Dossier preparation –

    • In collaboration with the Regulatory Affairs Manager, manage the preparation of relevant dossier sections to support Veterinary license applications including the relevant sections of Modules 2, 4 and 5.

     Leadership

    • Managing a small team of clinical experts to support the Veterinary portfolio development at the company.
    • Coaching/mentoring – support members of team with problem solving and skills development to aid learning and early problem resolution
    • Manage applicable clinical affairs budget and cost centre activities required for veterinary clinical activities.

     Veterinary Business Strategy –

    • Together with the Business Development Manager and relevant technical experts within the company, support existing veterinary partnerships with external partners as well as working to identify new development opportunities for the development of veterinary medicines for the company.

 

Minimum Qualifications and Experience:

  • Bachelor of Veterinary Medicine.
  • Significant clinical practice experience in companion animal space, ideally to include clinical research and in a cGxP environment.
  • Familiarity with cGxP in pharmaceutical manufacturing.
  • Familiarity with concepts of Regulatory Approval process for veterinary pharmaceutical products.
  • Technical knowledge of clinical research in the Veterinary space, with emphasis on small animal practice.
  • Good negotiating skills.
  • Multi-tasking- ability to manage conflicting deadlines.
  • Good planning and organizational skills.
  • Working knowledge of EDMS (Electronic Document Management System.)
  • Ability to understand complex clinical terminology and aptitude to learn new skills in the area of clinical research though working with external experts and CROs.

 

QCQA Chemist - Waterford City

Responsibilities:

  • Sampling and testing of raw materials in-process materials, finished and stability products.
  • Assist at a technical level in out of specification investigation and non-conformance management.
  • Participate in lab process validations, cleaning validations and equipment qualification.
  • Participate in site validations for the process.
  • Involved in ensuring that the laboratory is compliant to regulatory systems.
  • Sampling and testing of materials, utilities and environment.
  • Ensure all operations are conducted in accordance with GMP’s and good scientific principles.
  • Manage documentation and equipment maintenance systems within the laboratory.
  • Review chemical analysis data of raw materials, in process and finish products and assess the results and action as appropriate.
  • Control and management of stability activities including the monitoring of stability chambers.
  • Provide product support by completing line clearances.
  • Involved in updating documents within the site.
  • Support quality aspects of materials management including supplier approval, supplier complaints and specification management.

 

Minimum Qualifications and Experience:

  • Degree in Chemistry with 5 years’ experience in a laboratory environment.
  • Minimum 1 to 2 years’ experience in a regulated pharmaceutical/medical device environment desirable.
  • Experience of method validation and method transfer.
  • Familiarity with OOS management required.
  • Validation experience within a laboratory.
  • Stability experience desirable.
  • Experience in the use of HPLC, GC, FTIR, UV, TOC etc. as well as classical wet chemistry analyses.
  • Full understanding of the requirements of the Regulatory Standards.

 

9444 - Automation Engineer - Carlow

Purpose:

The Project Engineer will work with a team onsite in Carlow and be responsible for the validation of Automation OEM and PC Controlled Laboratory Systems. The candidate will need to have experience in validation and support of Laboratory and/or OEM automation systems/IT applications. The candidate is expected to be self-motivated and develop an understanding of the business. Previous experience of working in a pharmaceutical/GMP environment is essential.

 

Responsibilities:

  • Project oversight from design to hand over to business.
  • Deliver required documentation through the project lifecycle including but not limited to Quality Plans, Requirement Specifications, Tracability Matrix, AIQ, Quality Summary Reports.
  • Conduct validation activities for OEM or Lab systems in accordance with Quality Standards and Practices and GMP guidelines.
  • Work with site QAIT to ensure quality throughout the project lifecycle.
  • Coordinate with various stakeholders from IT/Automation and Business.
  • Configuration of OEM or Lab systems as per requirement specification and building of configuration Specifications
  • Completing risk assessments.
  • Communication and coordination with vendors.
  • Adhere to Data integrity standards.
  • Develop, maintain and keep to project plans and deadlines.
  • Support during commissioning and vendor IQ/OQ testing.

 

Minimum Qualifications and Experience:

  • Experience with OEM or lab system validation.
  • Experience with OEM or lab system administration.
  • Experience with OEM or lab system commissioning and configuration.
  • Experience in regulated GMP environment.
  • Experience of ER/ES and 21 CFR part 11 compliant software desirable.
  • Knowledge of GAMP.
  • Experience working in a Win 10 environment is an advantage.

 

2019-288 - Principal Engineer - Reliability and Maintenance - Waterford City

Responsibilities:

  • Design and optimize maintenance strategies, procedures and methods of work execution.
  • Lead the planning and scheduling of routine maintenance work.
  • Lead A3 project team to resolve repetitive equipment faults or process instabilities.
  • Working with Maintenance/Engineering to optimise planned maintenance routines.
  • Carry out quality inspections on jobs, work execution, identify improvements in tasks.
  • Liaise with client departments, customers and other engineering and production colleagues.
  • Arrange specialist procurement of fixtures, fittings or components.
  • Support the control maintenance costs.
  • Work with specialist equipment, such as programmable logic controllers (EAM, HMI), which control machinery on factory assembly lines.
  • Coach maintenance and engineering excellence strategies to help with installation and commissioning guidelines.
  • Deputize for Maintenance or Engineering Manager on occasion.
  • Support planning and scheduling to minimize impact to HVM operations.
  • Act as key site contact for maintenance excellence initiatives.

 

Minimum Qualifications and Experience:

  • 10+ year’s experience of maintenance related roles in high-volume industries with a significant technology content. Extensive hands-on experience of systems development and deployment, staff engagement and change management. Knowledge of medical device and/or pharmaceutical production preferred (cGMP / FDA regulated environment).
  • Bachelor’s in engineering or other technical discipline preferred. Experience in managing or leading engineering improvement projects, technical or systems related.
  • Knowledge of auto report generation, PLC I/O machine connectivity and equipment or engineering system reliability metrics development advantageous.
  • Experience in EAM/CMMS systems and system development.
  • MRO stores systems experience.
  • Proven ability to support Electronic Asset Management System deployment and technology development.
  • Self-Directed, excellent communication skills on technical subjects. Ability to form relationships with stakeholders from many sites and work within cross functional teams.
  • Experience of building effective MRO stores operating systems, Space management, new technology development for inventory control and cycle counting.
  • Excellent teamworking skills to work cooperatively and liaise with people at all levels.

 

2019-287 - Shift Engineer - Maintenance and Reliability - Waterford City

Purpose:

Improve equipment performance and reliability through technical knowledge and people leadership. This role will include the planning & execution of preventive and reactive maintenance programmes and the leadership of a group of technicians on shift. Technical knowledge & and employee supervision, and development are key aspects of the job.

 

Responsibilities:

  • Implement preventative maintenance programmes.
  • Monitor and drive improvements in the effectiveness of all maintenance activities.
  • Develop training plans for technicians.
  • Own, monitor and report and implement improvements in equipment OEE.
  • Provide details of shortfalls and associated improvement plans.
  • Set goals for the shift technician group.
  • Propose and action projects designed to improve all relevant maintenance KPIs etc.
  • Participate in the recruitment of staff as required.
  • Work with Procurement and Logistics groups on the control of equipment spares.
  • Complete Quality and Safety CAPA activities.
  • Ensure all work is executed in line with health and safety and quality system requirements.

 

Minimum Qualifications and Experience:

  • Education: Bachelor’s Degree in Engineering or other relevant, technical equivalent.
  • Experience: 5+ year’s experience of engineering/ maintenance roles in high-volume industries with a significant technology content
  • 3+ year’s supervisory experience advantageous.
  • Extensive hands-on experience of preventive/ reactive maintenance, technician supervision/ interaction and high-speed automation.
  • Knowledge of medical device and/or pharmaceutical production preferred (cGMP / FDA regulated environment).
  • Knowledge of automatic measurement and reporting of OEE and related production data would be advantageous.

 

2019-276 - QA Specialist - Waterford City

Purpose:

Reporting directly to the Quality Assurance Team Leader, as a critical leader for the company, you will play an integral role in providing day to day Quality and compliance support to the sterile manufacturing operations.

Responsibilities:

  • Working as part of the Quality Assurance team on site ensuring products are manufactured, stored and packaged in accordance with cGMP
  • Implement and support a batch release system in the QA function of Sterile Manufacturing
  • Support the development of GMP training packages and delivery of training
  • Participate in the preparation and review of procedures and batch documentation
  • Review and approval of deviation, CAPA’s, quality events and tasks
  • Ensure the quality system at the company is effectively implemented and maintained
  • Acts as Quality Point person for systems / processes providing guidance / feedback on quality issues
  • Perform timely review of documentation / investigations / reports highlighting and assisting in the resolution of concerns commensurate with the risk
  • Work with relevant departments to ensure timely closure of quality actions / findings
  • Actively contribute to continuous improvement initiatives
  • Conduct duties in a safe manner and report all safety issues or concerns

 

Minimum Qualifications and Experience:

  • Bachelor’s degree in a science related subject is essential
  • 3 years experience in a manufacturing environment, sterile experience is preferable
  • Effective technical knowledge of sterile manufacturing processes
  • Operational experience of quality systems in a dynamic manufacturing environment
  • Knowledge of requirements for cGMP, US and EU regulatory requirements
  • Full understanding of relevant quality and compliance regulations
  • Able to manage projects to plan/budget
  • Effective facilitator
  • Understands KPI’s for the team and site
  • Must be able to respond quickly to unplanned events, technical issues and changing needs from development programs
  • All applicants must be open to shift work

 

9384 - Senior Process Engineer - Cork

Purpose:

Provide process engineering services in support of the design, construction, commissioning and qualification of a new vial filling line. The job-holder works with the company’s Process Engineering Team to act as client owner representative to deliver integrated process engineering services to meet the Project Objectives. The Process Engineer will lead the delivery of a vial wash / tunnel / filler equipment package and will be a key member of a wider team focused on the retrofit of an existing sterile manufacturing facility for a new product.

 

Responsibilities:

  • Support GES Process Lead to implement a Process Design based on the scope of Process Requirements provided by the company Technology Transfer and Process Development Groups.
  • Lead cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables.
    • Ensure all project stakeholders are informed and consulted on key process suite activities and decisions.
    • Ensure team is delivering to plan against project milestones and provide status reports to project Tiers and stakeholders.
    • Escalate issues, constraints and risks as required
  • Act as client owner representative to self-execute critical design deliverables and provide direction and oversight of design progression by an Architect & Engineering design firm.
    • Ensure IFC Process Flow Diagrams, P&IDs meet process needs.
    • Lead vendor management and equipment testing to verify User Requirement Specifications and Equipment Specifications are met.
    • Manage closeout of process safety deliverables including PHA (Hazops) and machine safety checklists.
    • Ensure company Global and Cork site engineering standards, procedures and practices are followed.
  • Support GES C&Q Lead to coordinate preparation and lead FATs/C&Q field execution.
    • Review and approve system lifecycle documents including Criticality and Risk assessments, FAT documentation, C&Q documentation.
    • Manage installation / start-up / testing of process systems through OQ completion. Interface with cross-functional team to ensure systems’ post-OQ (PQ, PPQ) readiness.
  • Liaise with stakeholders, equipment vendors, business partners, and SMEs at other sites within the company Manufacturing Network as required to support Project.
  • On occasion, the job-holder may also undertake Project Engineering duties including:
    • Preparation of project related deliverables such as schedules, work plans, equipment cost tracking
    • Coordination of project activities between stakeholders

 

Minimum Qualifications and Experience:

  • Minimum qualification B.Sc. or M.Sc./ M.Eng Degree in Engineering, preferably Chemical or Biochemical Engineering or equivalent discipline; equivalent is defined as a Biotechnology or Industrial Chemistry Degree with basic the elements of chemical/biochemical engineering fundamentals as applied to biotechnology/bioprocessing
  • Minimum of 5 years post academic process engineering experience in a biopharmaceutical processing design, construction & start-up environment
  • Demonstrated ability to lead / influence teams in matrix environment
  • Excellent communication/presentation/organizational skills
  • In depth understanding of process engineering and technologies pertinent to unit operations including sterile filling.
  • Knowledge on the application of Disposable Technologies
  • Knowledge of PLC process control platforms and industry SDLC methodology
  • The role will require periods of travel. Flexibility is required in this regard.

 

9060112 - Investigation Specialist - Dublin

Purpose:

This position is responsible for conducting and documenting investigations associated with the company’s Quality Control Laboratory – Laboratory Investigation Reports (LIRs) and deviations. In this role, you should have excellent investigational, root cause analysis and problem-solving skills. Relationship building, a high attention to detail and excellent verbal and written communications skills are vital to success in the role

 

Responsibilities:

  • Conduct and document investigations associated with the company’s Quality Control Laboratory in a complaint and timely manner.
  • Conduct root cause analysis.
  • Develop and document Corrective and Preventative Actions (CAPAs) and associated CAPA Effectiveness Checks (EC).
  • Track and trend investigations and associated root cause types.
  • Provide training and mentoring for Laboratory Staff.
  • Identify process improvements within the function and drive the initiative forward to implementation and effectivity
  • Comply with internal SOP’s, standards and associated training .
  • Support the Quality Control, with responsibility to develop processes.
  • Responsible for assigned LIR, CAPA’s, Change Controls & Deviations program and initiate Corrective Action plans in the company’s Quality Management System, TrackWise.
  • Maintain regular and proactive communication with all stakeholders

 

Minimum Qualifications and Experience:

  • At least 5 years’ working in Pharmaceutical quality operations
  • Degree in science/pharmaceutical related subject
  • Knowledge and understanding of GMP standards
  • Strong problem solving experience
  • Familiar with continuous improvement initiatives
  • High level of experience of conducting Laboratory Investigations, root cause analysis and CAPA development.
  • Highly Computer literate, with MS Office (Word, Excel)
  • Experience of provision training to others
  • Experience of working in a GMP Quality Control Laboratory or Quality Assurance Unit

 

2019-236 - Senior Regulatory Affairs Specialist - Waterford City

Responsibilities:

  • Support all aspects of the EU Authorised Representative function in Ireland for the company.
  • Deputise for the Regulatory Affairs Manager for all regulatory body communications.
  • Provide EU Regulatory subject matter support to the Vision Care business for key projects and activities.
  • Serve as the person responsible for regulatory compliance for the EU Authorised Representative.
  • Develop and maintain a good knowledge of the Vision Care product portfolio.
  • Verify the EU Declaration of Conformity, Technical Documentation and Conformity Assessment carried out by the legal manufacturer.
  • Maintain the Authorised Representative registration with the Irish competent authority (HPRA) and maintain product registrations for Vision Care products.
  • Submit Field Safety Corrective Action (FSCA) Reports and Field Safety Notices (FSN) in the EEA, Switzerland and candidate countries on behalf of the legal manufacturer.
  • Field questions from competent authorities regarding product performance and/or vigilance and recall on the EU market.
  • Work with the legal manufacturer to provide responses to questions from competent authorities.
  • Participate in notified body and competent authority inspections of Vison Care legal manufacturer and manufacturing sites.
  • Manage the process for provision of certificates of free sale for Vison Care to support maintenance of business and/or market expansion including authentication, apostille and embassy legalization.
  • Upgrade the Authorised Representative policies, procedures and work instructions for EU MDR compliance.
  • Provide advice regarding interpretation of MDD 93/42/EEC and MDR 2017/745 including associated guidance (e.g. Meddev, Common Specifications etc.).
  • Support key EU MDR work streams (e.g. economic operators, technical files, quality systems).
  • Contribute to discussions internally and with notified body and competent authorities.
  • Willingness to travel on company business 10-15% of time.

 

Minimum Qualifications and Experience:

  • Minimum bachelor’s Degree BS in an engineering or scientific discipline or a Master’s degree MS in regulatory affairs or a related discipline.
  • 4-5 years’ experience in regulatory affairs.

 

2019-234 - Engineer - Process and Equipment - Waterford City

Description:

This position is to support manufacturing systems. Technical expertise is required to maintain, develop, debug and troubleshoot process & equipment issues.

Responsibilities:

  • Develop and implement process and equipment improvements with minimal impact to production operating under 24/7 environment.
  • Identify and eliminate repetitious machine failures.
  • Provide support to the Manufacturing, Maintenance, and Equipment Design groups.
  • Utilise Lean Six Sigma tools along with data to drive continuous improvement. Objective to minimise scrap, increase yield, reduce turn-around-time, minimise manufacturing downtime and costs and ensuring quality manufacturing within given specifications
  • Developing a detailed understanding of the process and automation systems in the manufacturing process, and sharing of technical expertise with colleagues.
  • Develop methods to ensure personnel engaged in maintenance activities have sufficient knowledge to perform their assigned tasks.
  • Generate documentation and SOPs associated with each of the equipment or process systems as required
  • Present, where appropriate, technical data to internal/external audit and inspection groups.
  • Ensure highest level of Health and Safety is considered and adhered to at all times for self and others
  • Equipment installation and validations
  • Process \ Equipment Engineers may lead projects \ project teams

Minimum Qualifications and Experience:

  • Bachelors in Engineering (mechanical\electronic) preferred.
  • A minimum of 4 years in technical role in high volume manufacturing environment preferred.
  • Good problem solving abilities – able to identify facts, consider alternative approaches and evaluate the most appropriate action.
  • Six sigma experience preferred.
  • Medical device and/or pharmaceutical industry experience preferred
  • Experience working in a validated environment with strong discipline with regard to change control is preferred.
  • Ability to share technical expertise with colleagues, must be able to express information clearly and concisely both verbally and in writing

 

2019-232 - Engineering Project Manager - Waterford City

Description:

Engineering Project Manager is responsible for the leadership of engineers and Project Management for new medical device manufacturing systems, products and cost improvements.

Responsibilities:

  • Use skills of analysis to identify, quantify and justify improvement opportunities.
  • Develop URS documentation for equipment and machine controls software systems.
  • Develop and implement new technologies and systems to support R&D projects.
  • Create and manage project schedules and budgets.
  • Communicate project information to all stakeholders (across many sites).
  • Identify, manage and mitigate project risk.
  • Identify and resolve project issues.
  • Demonstrate leadership skills to engage team members.
  • Demonstrate team building skills with motivated team members working well together.
  • Job will require travel to the USA and central Europe as project mix dictates.

Minimum Qualifications and Experience:

  • Bachelor level degree in Engineering or other relevant technical equivalent. Master qualification advantageous
  • 10+ years’ experience of project execution and supervision of engineers
  • Experience with medical device and/or pharmaceutical production required (cGMP / FDA regulated environment)
  • Knowledge of some of the following; software development life-cycle, GAMP V, SPC, DOE, Statistical Analysis, and Project Management (PMI certification a plus)
  • Project Management of high volume, low-cost manufacturing systems (may include pneumatics, PLCs, motion control, robotics, HMIs and SCADA)
  • Capable to lead, motivate and access engineers and others in project execution and technical development work streams
  • Self-directed. Excellent communication skills. Ability to form relationships with stakeholders from many sites and work within cross functional teams

 

Senior Project Coordinator (Project Manager R&D) - Clonmel

Responsibilities:

  • Responsible for compliance with applicable corporate and divisional policies and procedures. Estimates project levels of effort and resource requirements by using standard estimating techniques and tools, and by working with appropriate staff to understand scope of effort.
  • Prepares project plans, schedules and budgets by using project management tools such as Microsoft Project and by working with appropriate staff to understand tasks necessary to complete project.
  • Directs project execution by assigning tasks, tracking project schedules, identifying risks, and developing and executing contingency plans.
  • Assures project quality by using standard development methodologies and by working with the Supplier Quality Associate (SQA) to develop and execute project quality plans. Communicates project status by preparing standard status reports, and by participating in departmental and customer project status update meetings.
  • Resolves project issues by working with team members, project customers, and others as appropriate.
  • Participates in external project management organisations, conferences and seminars to keep current with industry best practices in project management by joining professional associations and implementing a professional development plan with focus on project management.

Minimum Qualifications and Experience:

  • National Framework of Qualifications level 7 qualifications in a relevant discipline.
  • 4+ years of related work experience or an equivalent combination of education and experience

 

9060112 - Laboratory Investigation Specialist - Dublin

Description:

This position is responsible for conducting and documenting investigations associated with the company’s Quality Control Laboratory – Laboratory Investigation Reports (LIRs) and deviations In this role, you should have excellent investigational, root cause analysis and problem-solving skills. Relationship building, a high attention to detail and excellent verbal and written communications skills are vital to success in the role.

Responsibilities:

  • Conduct and document investigations associated with the company’s Quality Control Laboratory in a complaint and timely manner
  • Conduct root cause analysis
  • Develop and document Corrective and Preventative Actions (CAPAs) and associated CAPA
  • Effectiveness Checks (EC)
  • Track and trend investigations and associated root cause types
  • Provide training and mentoring for Laboratory Staff
  • Identify process improvements within the function and drive the initiative forward to implementation and effectivity
  • Comply with internal SOP’s, standards and associated training
  • Support the Quality Control, with responsibility to develop processes
  • Responsible for assigned LIR, CAPA’s, Change Controls & Deviations program and initiate
  • Corrective Action plans in the company’s Quality Management System, TrackWise
  • Maintain regular and proactive communication with all stakeholders

Minimum Qualifications and Experience:

  • At least 5 years’ working in Pharmaceutical quality operations
  • Degree in science/pharmaceutical related subject
  • Knowledge and understanding of GMP standards
  • Strong problem solving experience
  • Familiar with continuous improvement initiatives
  • High level of experience of conducting Laboratory Investigations, root cause analysis and CAPA development
  • Highly Computer literate, with MS Office (Word, Excel)
  • Experience of provision training to others
  • Experience of working in a GMP Quality Control Laboratory or Quality Assurance Unit

2019-225 - Senior Molding Engineer - Clonmel

Description:

Plays a leading role in the area of injection molding related activities, including new tool qualifications and resolution of supply and quality issues encountered during day-to-day running of the business.

Responsibilities:

  • Responsible for design, development, implementation and ongoing support of polymer-based injection molded components used in the manufacture of our client’s products offerings.
  • Serve as both technical expert in the field of injection molding as well as a project manager for molding related projects, working regularly with Research and Development (R&D), Operations, Supply Chain, Quality and suppliers.
  • Manage molded commodities over life cycle including tactical and strategic activities to support ongoing business such as product, process, quality and cost improvement initiatives, supplier and resin changes, material obsolescence.
  • Troubleshoot molding issues in conjunction with supplier and lead/support internal investigations as required.
  • Work closely with molding suppliers to ensure reliable supply of parts.
  • Responsible for ensuring adherence to quality system through creation and update of specifications, metrology, setup, design control and qualification and Failure Models and Effects Analysis (FMEA)
  • Identify critical dimensions and work with suppliers to ensure proper process controls are in place.
  • Must have proven ability to participate in team atmosphere, exhibit and create a sense of urgency and maintain effective working relationships with peers, customers and suppliers.
  • Concurrent management/support of multiple projects.
  • Create and maintain project schedules, lead and participate in cross-functional team activities to achieve program objectives.
  • Transfer of molds to new suppliers, start-up of new suppliers.
  • Participate in cross-functional teams to investigate and resolve molding issues.
  • Perform capacity analysis for molds, presses and assembly automation and make recommendations for future investment.

Minimum Qualifications and Experience:

  • Experience/Education
  • National Framework of Qualifications (NFQ) Level 7 qualification in a relevant discipline
  • 4+ years of relevant work experience or an equivalent combination of education and work experience.
  • Technical/Business Knowledge (Job Skills)
  • Wide application of technical principles, practices and procedures within the field of polymer component manufacture, in particular within the field of injection molding. Strong understanding of business unit functions and cross group dependencies/ relationships. Will perform role within quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
  • Cognitive skills
  • Works on problems of diversive scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of various technical alternatives and their impact.
  • Influence/Leadership
  • Establishes and cultivates an extensive network of support to facilitate completion of assignments. Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel. May lead a project team. Participates in determining goals and objectives for projects. Influences middle management on technical or business solutions. Interacts frequently with suppliers.
  • Planning/Organization
  • Plans and organizes non-routine tasks. Initiates or maintains work schedule. Establishes priorities of work assignments.
  • Decision making/Impact
  • Exercises judgment in selecting innovative, practical methods to achieve problem resolution. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure or resources.
  • Supervision Received
  • Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
  • Supervision Provided
  • May provide work direction and guidance to exempt and/or skilled non-exempt levels of employees; may be asked to evaluate performance of and assist in career development planning for subordinates.

Senior Quality Engineer (R&D) – Waterford City

Description:

Ensure that all required Quality systems are implemented and effectively operating in the R&D development Lab. Ensure that all R&D project activities are carried out in compliance with the requirements of Quality Systems, FDA and other regulatory agencies up to and including Process validation. Provide oversight for Design Management of contact lenses – from a Quality System and technical perspective. Provide Quality Support to Manufacturing Plant as required.

Responsibilities:

  • Support Development Lab activities from a quality systems perspective
  • Implement and effectively maintain compliance with regional directives and procedures across R&D activities
  • Review and approve all protocols and reports for R&D equipment qualifications
  • Review and approve all protocols and reports for the manufacture of Clinical Trial Materials
  • Review all batch history records for clinical trial materials prior to issuing QA Release memo
  • Provide Regional Quality support for all Design Control activities
  • Drive and oversee all Risk Management activities for new product development
  • Complete and provide Risk Management and Complaint data updates to Annual Product Quality
  • Reviews and for revision of Design Risk Analysis and Clinical Evaluation Reports
  • Review and approve all Process Validation protocols and reports for new products

Scope of Position:

  • Ensuring that Quality systems are effectively implemented and maintained in Waterford R&D
  • Ensuring Compliance with quality standards and GMP requirements for all product/ process development activities in the R&D program of work through participation in R&D process development teams and approval of protocols.
  • Regional Quality support for all Contact Lens development projects in Waterford from inception to successful technology transfer / scale-up.
  • Risk management activities through development and product lifecycle.

Minimum Qualifications and Experience:

  • Bachelor degree in Science or Engineering
  • Certified training in Quality Systems Requirements of FDA and ISO-13485
  • Certified training in Auditing of Quality Systems
  • Documented training in all relevant company Directive and Procedures
  • 5+ years relevant experience in a similar industry