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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TECHNICAL RESOURCING

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

R&D Data Reviewer - Waterford CIty

Description:

Our client a leading Pharmaceutical company based in Waterford requires an Analytical Development Data Reviewer to support Product Development and Clinical Supply and review all data associated with developing, transferring or validating analytical test methods as applicable.

Minimum Qualifications and Experience:

  • Qualified to a minimum of degree level in chemistry, pharmaceutical science or a related discipline.
  • At least five years’ experience working in a related technical environment.
  • Proficient in the use of HPLC & associated problem solving.
  • Working knowledge of Empower laboratory software.
  • Strong attention to detail.
  • Strong analytical ability. 

Responsibilities:

  • Review all data associated with the development, transfer or validation of robust, sound analytical methods
  • Review test methods, validation protocols and reports as applicable
  • Prepare submission documentation in support of license applications
  • Take part in /lead Laboratory Investigations
  • Attend internal project review meetings as required
  • Assist in the preparation for customer/ regulatory inspections
  • Identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement
  • Review raw data from the testing of raw materials, in-process samples and finished products in a timely & efficient manner to ensure quality and efficacy of the product
  • 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
  • Review all data to ensure that it is completed correctly, in line with data integrity guidelines, free from errors, omissions or defects in order to achieve a high level of customer service and cGMP
  • Perform additional team tasks as agreed to support effective running of the Business
  • Support all other on-going laboratory functions & requirements

Quality Assurance Officer - R&D – Waterford City

Description:

Our client a leading Pharma company based in Waterford requires a Quality Assurance Officer to support the QA Manager with the development, implementation and maintenance of the company quality standards and systems to ensure that products comply with Marketing Authorisations, documentation, specifications and cGMPs.

The main purpose of the role is to support manufacturing areas with QA support including but not limited to the following:

  1. Real time in situ batch documentation review
  2. Real time assessment of manufacturing events from a QA perspective
  3. Provide clearance to precede instructions in manufacturing following unplanned events

Minimum Qualifications & Experience:

  • A third level degree incorporating Quality Assurance/ Management
  • Have minimum 2 years relevant experience in a Pharma role / GMP related role
  • Experience with desktop and internet-based software applications (e.g. electronic document management system, MRP system) an advantage but not essential
  • Excellent communication and presentation skills
  • Focus on quality and detail
  • Careful planning to achieve accurate and timely result
  • Ability to define and manage own tasks and schedules
  • Experience performing and assessing risk/impact assessment an advantage

Principal Scientist - Lyophilisation - Waterford City

Purpose:

The role is to support the the design and scale-up of lyophilisation processes suitable for clinical production, including cycle optimization, robustness studies, and technology transfer.  Candidates should have biotechnology educational attainments, a minimum of five years’ experience within the pharmaceutical industry, preferably in a Biopharma role with significant exposure to Lyophilisation & cycle development, and have ideally worked within an aseptic fill finish environment.  

Responsibilities

  • Advise on lyophilisation cycle development, optimization, scale up and Technology Transfer of finished products using state of the art techniques
  • Design and execute accelerated stability testing plans that demonstrate suitability of Lyophilised formulations
  • Complete required batch documentation records with accuracy and legibility
  • Ensure product quality by performing in-process checks, complying with current good manufacturing practices
  • Track and report deviations to a process, initiating quality improvements and participating on quality improvement projects as required.
  • Act as R&D liaison between relevant Managers, Q A, Research, Tech Services, Engineers and Maintenance personnel in all matters regarding freeze drying
  • Participate on manufacturing project teams to assist with cycle development through collaboration with R&D.
  • Review work scope, rationale, approvals, changes to appropriate equipment/systems and re-qualification activities
  • Assist in the training of sterile operators or cross-training in other areas.
  • Troubleshoot and perform adjustments on equipment as required.
  • Ensure that all work is carried out in compliance with the required standards to conform to company, cGxP, health and safety, environmental and regulatory requirements.

Qualifications:

  • You MUST be passionate about Lyophilisation and Biopharma
  • An honours degree in Science/Biotechnology (or a related discipline)
  • You MUST have at least 5+ years’ experience
  • Significant exposure to Lyophilisation & cycle development
  • Ideally have worked within an aseptic fill finish environment
  • Demonstrated knowledge in pharmaceutical / biopharmaceutical technical / manufacturing operations.

Process Lead - Sterile - Waterford City

Purpose:

The role is to provide scientific/engineering leadership across all the disciplines involved in Technology Transfer and Sterile Operations.  This role would suit candidates with biotechnology academic attainments, at least 5 year’s experience in working within sterile operations/tech transfer and fill finish manufacturing.

Responsibilities

  • Provide scientific/engineering leadership across all the disciplines involved in Technology Transfer and Sterile Operations
  • SME for introduction of single use systems and assessment of their use in terms of extractables, leachables and container closure
  • SME for sterile formulation of biologic products
  • Support all aspects of the manufacturing process from formulation and filling to visual inspection
  • Technical review of change controls for impact to product quality, safety and efficacy
  • Provide on-floor technical support and troubleshooting
  • Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing
  • Technical protocol and summary report generation as related to technical studies executed in direct support of GMP manufacturing activities
  • Collection, organisation, trending, and analysis of GMP manufacturing data
  • Identify manufacturing best practices across the network and lead or participate in teams to implement best practices
  • Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process
  • Assist the team with development of objectives and ensures alignment with site goals
  • Assist the Program Lead to generate and execute a Technology Transfer Master Plan
  • Responsible for ensuring availability of knowledge, information, expertise and training as needed for the activities necessary to execute the transfer and all testing to support the Technology Transfer process, as relevant to the Receiving Unit
  • In association with the Sending unit Technical lead define the risks, gaps and closure plans
  • Lead the pre-GMP line activities (Development, Pre-Eng, Eng Run, as applicable) along with all associated protocols and reports
  • Ensure information transfer to Process Engineering group for all cycle development activities
  • Review sampling plans for all activities and ensure compliance with all TT requirements
  • Support the generation of the Control Strategy
  • Ensure appropriate scientific and engineering documentation is collated and approved for a robust Process Flow document
  • Ensuring that operational modifications or processing gaps are identified and updated in the operational control strategy.

Qualifications

  • You MUST be passionate about Process, Tech Transfer and Biopharma
  • An honours degree in Science/Biotechnology (or a related discipline)
  • You MUST have at least 5+ years’ experience in the following areas:
    • mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling and visual inspection.
  • Significant exposure to sterile operations and/or Tech Transfer projects
  • Experience in fill-finish process development and/or manufacturing support with extensive practical knowledge of liquid fill operations.
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices
  • Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically sterile liquid fill operations.
  • Familiarity with protein handling and processing considerations and how operating conditions can impact Critical Quality Attributes.

Technical Services Analytical Team Lead - Waterford City

Description:

Currently seeking a Technical Services Analytical Team Lead. We are looking for someone who can prioritise and coordinate the execution of Technical Services Analytical activities in line with department and company requirements.

Responsibilities:

  • Assist the Technical Services Manager in achieving company goals
  • Day to day scheduling of laboratory activities
  • Working in real time by ensuring the laboratory work in progress is kept to a minimum.
  • 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 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
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement
  • Representing the Technical Services department at internal meetings and communications with customers.

Minimum Qualifications and Experience:

  • Relevant third level qualification
  • At least 5 years previous relevant experience

Quality Manager - Waterford City

Responsibilities:

  • To manage the compliance within the dept. and ensure that the area is operating in accordance to GMP
  • To provide support on any external investigations
  • To lead continuous improvement activities and support projects
  • Assist in any validation activities that may as the Quality representative within the project
  • To oversee the product and process performance using appropriate metrics Quality representative on the sign off of change controls, documentation and validation activities
  • To ensure that the procedures are up to date and in compliance to the global systems. To ensure that the records generated are accurate and completed in real time.
  • To review method validation protocols and reports on new/ existing test methods, as required.
  • To liaise with other departments on the communication of the true failures and supply support for any further investigation or documentation required to close out the failures.
  • To approve all reports generated due to any investigational work that is requested due to a complaint or a potential issue within the manufacturing site. To ensure that the data generated is accurate and generated in a timely manner to help close out issues and potentially release product.
  • Participate in inter-dept teams, as required to help improve the company.
  • Carry out all activities in compliance with company Safety Environmental Standard Operating Procedures.
  • Ensure that the activities completed during processing will not hinder the safety of other individuals within the area.
  • During validation activities support and risk manage process change initiatives to ensure appropriate level of validation and verification.
  • Lead projects for the introduction of new equipment within the site, ensuring that the correct level of validation is completed, that the relevant procedures are updated, and that there is a training plan in place.
  • Carry out Supplier Audits and internal audits when required.
  • Work in partnership with operations and Process engineering and other support departments to drive quality and cost Improvement initiatives
  • Additional requirements of the job will be specified by the Quality Director

Minimum Qualifications and Experience:

  • Degree in chemistry, science or related technical discipline
  • Experience as a working QP required
  • Full understanding of the requirements of the Regulatory Standards
  • The ability to assess and evaluate information to determine appropriate risk and required actions that are critical
  • Experience of scientific report writing including such documents as SOPs, protocols, deviations, reports etc
  • Have managed a QA department for 5 years
  • Ability to evaluate and assess information to determine appropriate risk and required actions is critical.
  • Good knowledge of Tablet manufacturing required
  • Experience in Medical Device manufacturing desirable
  • Knowledge of purified water and Environmental Monitoring systems

Senior Quality Engineer - Waterford City

Responsibilities:

  • Work closely with R&D during the development and introduction of new products and technologies ensuring all technologies meet data integrity requirements
  • Work with R&D team to ensure Suppliers associated with new production introductions are
  • Qualified as per Supplier Qualification requirements
  • Work with the R&D Team to ensure that all Quality Control Requirements for new products, and technologies are defined and understood and that they are transferable and maintainable in a production environment
  • Lead failure analysis PFMEA, to ensure functional specification requirements are fully met during validation
  • Technically understand the process in question, and provide input to and approval of, development protocols, process validation protocols, inspections and analysis of results
  • Drive the resolution, analysis and problem solving of new product related issues, working closely with both manufacturing Quality and R&D
  • Lead CAPA/Nonconformance activity when required
  • Ensure the efficient and timely transfer of Quality knowledge to manufacturing quality engineers and coordinate the training of quality engineers and quality technicians on new quality systems and equipment and products
  • Additional requirements of the job will be specified by the Quality Systems Manager

Minimum Qualifications and Experience:

  • Third level Qualification in Science or Engineering
  • Minimum 3-5 years’ experience in a regulated pharmaceutical/medical device with at least 2 years in a senior Quality Role essential
  • Full understanding and experience of the requirements of ISO 13485, 21 CFR Part 820 and Part 11 and data integrity requirements essential
  • Knowledge of Supply Chain and the Supplier Qualification requirements an advantage
  • Experienced lead auditor an advantage
  • Experience in providing Quality Support for Product Development and validation beneficial
  • Must be self-motivated, with ability to work on own initiative and prioritize
  • Must have experience of team working and excellent communication skills with the ability to motivate and influence people and drive corrective actions when necessary
  • High attention to detail
  • Statistics/Six Sigma Qualification beneficial

Senior Standards Compliance Lead - Waterford City

Responsibilities:

  • Manage standards compliance for CL sites ensuring sites have up to date site standards lists in place to provide support on any external investigations
  • Drive alignment and harmonization of standards within CL sites and initiate QCRs where required to bring sites into compliance
  • Field questions from competent authorities in regards to product performance and/or vigilance on the EU market and forward all correspondence to the legal manufacturer
  • Conduct assessments of new product registrations to confirm correct product specifications
  • Provide support to the Brexit and MDR projects for existing sites and ensure risks are assessed and mitigated
  • Provide expertise in areas of interpretation wrt MDD 93/42/EEC, EU 2017/745, ISO 13485 & QSR
  • Support audits & inspections (NB & FDA) of manufacturers, importers and distributors
  • Provide expertise in regards to implementation of MDR 2017/745 & common specifications, contribute to discussions internally and with notified body
  • Support EU MDR work streams e.g. economic operators, technical files, MDD renewals, quality systems
  • Work on providing Brexit deliverables for Local RA submission e.g. CFS, DOC, CFG – approve artwork QCRs
  • Provide PRRC support to the CL manufacturing and EU Authorised Representative
  • Coordinate the participation in standards groups e.g. ISO
  • Participate in local activities in Ireland e.g. HPRA meetings, NSAI, IMDA etc
  • Deputise for the Compliance manager as required
  • Attend key trade association meetings and conferences

Minimum Qualifications and Experience:

  • Bachelor’s Degree BS in engineering or scientific discipline (Chemistry, Biology, Microbiology, Pharmacy or related technical field)
  • Experience in Regulatory Affairs or Quality Systems is desired

Laboratory Training Specialist - Waterford City

Purpose:

To support QC/Stability, and Technical Service departments by ensuring all training related issues within the departments are executed correctly and efficiently.

Responsibilities:

  • Develop and maintain a robust laboratory training plan for all roles within the Laboratory.
  • Review the trends from training related deviations and propose effective preventative actions related to training requirements.
  • Review training metrics for compliance.
  • Evaluate the effectiveness of training for specific roles.
  • Assist in new Learning Management System implementation and maintenance from laboratory updates.
  • Liaise with Team Leaders & Managers to co-ordinate the induction and training of new laboratory staff as appropriate.
  • Prepare and deliver training presentations as required.
  • Ensure all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • Identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • Assist in the preparation for internal / customer/ regulatory inspections.
  • Draft, review or revise documentation within Eigen documentation management system
  • Health & Safety
    • Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
    • Report any defects or hazards
    • Ensure all laboratory personnel are suitably trained on any  safety requirements for working in the laboratory.

Minimum Qualifications and Experience:

  • A relevant qualification in Analytical Chemistry, Pharmaceutical science or related discipline.
  • At least three years experience working in a regulated environment. Experience in both testing and data reviewing is preferable with a proven track record of compliance in theses area.

QA/RA Supervisor– Galway

Purpose:

Our client a leading Medical Device company in Wexford requires a QA / RA Supervisor to join the team and manage the supervision of development, maintenance, and distribution of quality documents within the Quality Management System.

Responsibilities:

  • Management of the PMR system
  • Change Control Process
  • Documentation Control system for the QMS
  • Ensure continuous compliance
  • FDA inspections
  • ISO 13485 surveillance audits
  • Corporate audits
  • Internal audits
  • Customer audits
  • Customer complaint investigation, reporting, closure and trending
  • Review current technical product files for compliance to international requirements
  • Answer all customer regulatory requests and complaints
  • Design and implementing quality systems improvements
  • Support plant validation documentation programs as required, ensuring records are maintained

Minimum Qualifications and Experience:

  • Must hold an Engineering or science degree
  • Minimum 2-5 years’ experience in a Medical device quality systems role in an FDA regulated environment
  • Previous supervisory experience essential
  • Qualified systems lead auditor for ISO 13485 and MDD compliance
  • Competent in preparing written communication and correspondence
  • Previous Regulatory experience

Manufacturing Engineer (Projects) - Athlone

Description:

The Manufacturing Engineer (Projects) is required to act as the Engineering Team’s representative for ongoing projects. The manufacturing engineer (projects) will be responsible for overseeing projects ranging in nature from New Product Introduction, to improving machine capabilities and implementing continuous improvement projects. The right candidate will also ensure the projects comply with the relevant regulatory requirements as well as company specifications and requirements. This role will include design, scope definition, change control and project management.

Responsibilities:

  • Responsible for Manufacturing Engineering Projects, liaising with vendors and troubleshooting of process systems where required.
  • Participate on capital project teams through all phases of projects; these phases will include conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification.
  • Responsible for initiation and completion of deviations, CAPAs, and change controls for process systems including investigations relating to equipment malfunctions.
  • Oversee process system upgrades
  • Any other duties as required by management

Minimum Qualifications and Experience:

  • BEng in Chemical or Mechanical Engineering plus 3-4 years relevant experience in a cGMP commercial manufacturing environment or MS or MEng in Chemical or Mechanical Engineering plus 2-5 years relevant experience in a cGMP commercial manufacturing environment.
  • 3-6 years relevant experience in a cGMP commercial manufacturing environment (preferably Biopharma)
  • Experience in project management of small scale projects in a cGMP commercial manufacturing environment
  • Experience in troubleshooting and providing technical support for cGMP manufacturing operations and equipment in an aseptic processing environment
  • Experience with sanitary design and operation of manufacturing equipment, with an emphasis on Aseptic Filling (for both or either RABs or Isolator technology)
  • Ability to read and understand sophisticated architectural, equipment and system drawings.
  • Knowledge of and experience with GMP manufacturing systems (i.e. filling machines (Isolator and RABs technologies), ultrafiltration systems, autoclaves, parts washers, etc.)

QA Validation Specialist - Dublin

Responsibilities:

  • Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness and ongoing product disposition.
  • Provide QA support for risk based verification activities in the capacity of Quality Assurance Subject Matter Expert. Review and approval equipment/utilities verification documentation from design to post execution.
  • Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained/controlled.
  • QA support for implementation of Manufacturing Execution System (MES) computer system validation deliverables.
  • Review and approval of engineering functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols).
  • Authoring, review and approval of QA-related procedures.
  • Oversee the effective documentation and tracking of quality management system activities including deviations and change controls and CAPA.
  • Review and approve Validation protocols as required. (Examples include cleaning, process, method validation).
  • Support the vendor quality management programme.
  • Participate in regulatory inspections as required.
  • Develop and report quality metrics.
  • Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
  • Represents Quality Assurance to guide various projects and technical meetings, as needed.
  • Responsible for documenting and reporting compliance issues to management.
  • Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.

Minimum Qualifications and Experience:

  • B.Sc. in science/pharmacy with a minimum of 5 years’ experience in cGMP Quality environment to include biopharmaceutical experience.
  • Min 5 years QA experience in a pharmaceutical manufacture/biopharmaceutical environment. (BDS experience is essential).
  • Must have strong process knowledge to include upstream and/or downstream processing.
  • 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.
  • Knowledge of automation and IT systems a distinct advantage.

Fill Finish Validation Specialist - Dublin

Purpose:

The Senior Specialist Technical Services has primary responsibility for providing technical support of commercial and clinical drug product manufacturing operations performed at contract manufacturing organisations (CMOs). The successful candidate will be responsible for providing scientific and engineering support through all phases of the product lifecycle, including technology transfer, process scale-up, process validation and routine commercial or clinical manufacturing. The position requires effective cross-functional collaboration with CMOs and internal partners including Manufacturing, Process Development, Engineering, and Quality to provide support of manufacturing.

Responsibilities:

  • Provide significant fill-finish technical expertise to support all aspects of the manufacturing of commercial and late stage clinical products at CMOs.
  • Lead troubleshooting efforts and high-level deviation investigations in conjunction with contractors and internal partners (Process Development, Manufacturing, and Quality).
  • Support all aspects of the manufacturing process from raw material selection and specification through formulation and filling to visual inspection, testing and release.
  • Technical review of change controls for impact to product quality, safety and efficacy.
  • Provide on-floor technical support and troubleshooting at the CMO facility.
  • Identify and then lead process optimization initiatives and address opportunities for efficiency and capacity improvements in all areas of manufacturing.
  • Technical protocol and summary report generation as related to technical studies executed in direct support of GMP manufacturing activities.
  • Collection, organisation, trending, and analysis of GMP manufacturing data.
  • Identify manufacturing best practices across the network and lead or participate in teams to implement best practices.
  • Support establishment of validation plans and evaluation of drug product production site options
  • Provide SME input for IND, BLA and other technical documents for regulatory agency submission in support of manufacturing process operated at CMOs.
  • Up to 25% international travel required.

Minimum Qualifications and Experience:

  • Minimum BS degree in Scientific (Biochemistry, Biology, Chemistry) or Engineering (Chemical, Mechanical) related field.
  • Minimum of five years’ experience in in fill-finish process development and/or manufacturing support with extensive practical knowledge of liquid fill operations.
  • Experienced in relevant unit operations including mixing, formulation, sterile filtration, sterilisation, aseptic processing, component processing technologies, liquid filling and visual inspection.
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product drug manufacturing operations are cGMP compliant.
  • Experience of technology transfers and implementing new clinical and commercial biopharmaceutical manufacturing processes, specifically sterile liquid fill operations.
  • Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections.
  • Familiarity with protein handling and processing considerations and how operating conditions can impact Critical Quality Attributes (CQA).
  • Experience of working with CMOs would be a distinct advantage, demonstrating strong communication and influencing skills.

Scheduler - Dublin

Purpose:

In this role the candidate will be responsible for developing, overseeing and maintaining master project schedules. Provide scheduling information and assistance needed to manage projects in compliance with the objectives of the Project Plan.

Responsibilities:

  • Produce layouts and filters per owners, discipline and functions
  • Ability to extract specific information from schedules by filters, histograms, S-curves,
  • Implement earned value progress measurement system
  • Publish variance reports and schedule showing planned versus earned versus forecast.
  • Analyze and publish critical path activities proving movement on critical paths
  • Publish look ahead schedules weekly to 3 months.
  • Establish routine progress update procedures in line with monthly end cost reports.
  • Establish baseline metrics for benchmarking.
  • Liaise with site function groups including QA/QC, Regulatory, Technical Services and Operations to control and maintain project schedule.
  • Implement routine progress updates with all functions.
  • Integrate a variety of schedules and information from Microsoft project and previous versions of Primavera.
  • Resource load schedule by either metrics or man hours.
  • Ability to organize, prepare and facilitate interactive planning and schedule review sessions with project team and site function groups.
  • Other duties as required.

Minimum Qualifications and Experience:

  • Engineering, Computer Science or Construction Management degree (or equivalent experience)
  • A planner with over 5 years experience in Pharmaceutical/Biopharmaceutical projects.
  • Experience with Primavera P6 and Microsoft Project.
  • Ability to plan a projects scope of work to assist project management team build and baseline project schedules.
  • Ability to prepare written, graphical and technical information from all aspects of the schedule (i.e. histograms, S-Curves, deployment schedules, etc.)
  • Ability to use and develop reports and graphs from excel and word.
  • Exhibit exceptional organizational and multi-tasking skills including ability to challenge normal schedule thinking.
  • Experience in the biopharmaceutical industry from commissioning/qualification, operation h to process validation & ramp.

Finance Analyst - Dublin

Purpose:

The Finance Business Partner role will support the Director, Finance in all aspects of Financial Planning and Analysis and process setup and improvement from a Global perspective in addition to providing end to end Business Partner support to Global Quality function & process owner for Payroll, Headcount & Assessments.

Responsibilities:

  • Month-End Close Activities
    • Consolidated month end analysis of results during the close cycle
    • Business partnering with Global Quality functions during month end close to deliver accurate results & support business decisions
    • Consolidation of monthly corporate reporting submissions
    • Coordination & preparation of Global Quality Metrics presentations for issuance to Global Operations & Finance Leadership
    • Analysis of Global Operations payroll variances and reporting of underlying drivers
    • Headcount reporting and analysis of variance
    • Review of monthly assessments to Capex, P&L Expense, Inventory
  • Planning and Analysis
    • Partner with Global Quality functions in preparation of their forecast, budget and strategic plan for operating expenses and Headcount
    • Consolidate forecast, budget and strategic plan for Global Quality Gross and Net Expenses & Headcount/Personnel & present to functional & finance leadership
    • Global Headcount forecast consolidation
    • Prepare analysis of variances vs. budget and previous forecast re headcount & payroll
    • System submission of forecast, budget and strategic plan
    • Preparation of functional budget and strategic plan presentations for Global Quality function & presentation of functional views
    • Development of standardized templates for use in budget and strategic Planning Process
    • Overall responsibility for assessments to Capex, P&L Expense, Inventory form a Global Operations perspective
  • Policies and Procedures
    • Prepare policies and procedures for areas of responsibility
    • Provide responses to internal and external auditors for areas of responsibility
    • Maintain strong control environment
  • Special Projects & Other responsibilities
    • Lead and participate in process improvements in areas of Headcount, Payroll & Assessments
    • Delivery of training to Business partners in Finance areas & standardization of Business Partnering process
    • Cross train in other areas within FP&A team as backup support
    • Ad hoc requests in support of business decisions as required
    • Owner of BPC master data for Global Operations
    • Participate on special projects related to global quality, supply chain, and inventory on an as-needed basis

Minimum Qualifications and Experience:

  • Qualified accountant (CIMA/ACA/ACCA)
  • 0-4 years financial experience preferably in an operations environment
  • Experience in US multinational
  • Knowledge of SAP
  • Financial modelling skills a strong plus
  • Experience in process improvement/lean/Six Sigma initiatives a strong plus
  • Computer skills – Highly proficient in Microsoft Excel and Powerpoint

Payroll Analyst - Dublin

Responsibilities:

  • Ensure accurate and timely payroll performance for assigned entities in compliance with Sarbanes Oxley (SOX) requirements
  • Accountable for preparation/provision of monthly payroll instructions to external payroll providers, monitoring results and validating accuracy
  • Ensuring all stock plan adjustments are processed through the relevant country payroll according to local legislation
  • Processing payments of net pay via EFT and Internet banking
  • Coordination of Taxes/Social Charges, Pensions, Insurances payments
  • Respond to / address HR and / or employee queries arising on supported payrolls
  • Develop strong working relationships with the external payroll vendors and internal departments
  • Support accounting team with GL reconciliations
  • Escalate issues as appropriate to Associate Director
  • Keep him/herself informed and trained on latest payroll regulations / updates for entities supported

Minimum Qualifications and Experience:

  • IPASS or equivalent qualification,
  • Experience working with multiple vendors and IIPay an advantage
  • EMEA Payroll experience
  • Good computer literacy (MS Office, SAP, etc.)
  • Excellent organizational skills with the ability to work on own initiative and perform well under pressure with tight deadlines
  • Displays great attention to detail and analytical ability
  • A clear, fast thinker, able to translate business needs into pragmatic solutions and implement them
  • Strong positive attitude and interpersonal skills

Quality Assurance Specialist - Dublin

Responsibilities:

  • Provide quality and cGMP input and oversight for all start-up project activities through commercial readiness for biologics facility
  • Review and approval technical support documentation. (Examples include cleaning, process, method validation, risk assessments)
  • Review and approval of manufacturing batch records
  • Provide quality support for implementation of new product on SAP
  • Review and approval of functional area documentation
  • Authoring, review and approval of QA-related procedures
  • Oversee the effective documentation and tracking of quality management system activities including deviations and change controls, CAPA
  • Any other duties as required by management

Minimum Qualifications and Experience:

  • B.Sc. in science/engineering with a minimum of 4 years’ experience in cGMP Quality environment; or equivalent combination of education and experience.
  • Min 4 years QA experience in a pharmaceutical manufacturing environment
  • 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.

Quality Assurance Specialist - CSV - Dublin

Purpose:

The Quality Assurance (CSV) Specialist ensures that computerized systems for the facility comply with corporate policies, GMP and regulatory requirements over the entire system lifecycle. As a quality and compliance representative, the QA Specialist will be a key member of the MES Project team. This key role will provide the appropriate oversight for the implementation, validation and system modification of the MES System to ensure that the implemented batch records meet corporate policies, GMP and regulatory requirements.

Responsibilities:

  • Provide quality oversight and compliance support to implement and validate electronic systems in accordance with site computer system validation (CSV) procedures and requirements.
  • Review and approval of CSV and Qualification documents such as validation plans, protocols, test scripts, validation reports etc.
  • Serve as the QA CSV Subject Matter Expert for implementation and verification of Manufacturing Execution System (MES).
  • Provide Quality oversight for project deviations ensuring all are appropriately investigated and documented with appropriate corrective and preventative actions in place.
  • Support and review changes throughout the verification/validation phase and post release of the system through the change control system.
  • Participate and provide quality oversight in any required system risk assessments.
  • Review and approval of systems administration maintenance procedures to ensure computer systems are in a state of control.
  • Support internal and external audits and system vendor qualification activities.
  • Provide Quality Management with project updates, and communicate risk based escalation of issues as required.
  • Interface with relevant departments to ensure compliance with corporate policies, GMP and regulatory requirements.
  • Any other duties as required by management.

Minimum Qualifications and Experience:

  • B.Sc. in science/pharmacy with a minimum of 8 years’ experience in cGMP Quality environment to include biopharmaceutical experience.
  • Min 8 years QA experience in a pharmaceutical manufacture/biopharmaceutical environment.
  • Must have strong technical knowledge of Computer System Validation
  • Must have strong understanding of 21 CFR Part 11, Annex 11and Data Integrity Guidance’s and ability to assess compliance risks.
  • Must have 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.

Technical Services Specialist – Upstream - Dublin

Purpose:

The Cell Culture (Upstream) Technical Specialist has primary responsibility in supporting the startup and cGMP manufacture of biological bulk drug substance (BDS). The Technical Specialist will be part of the cell culture team to support the facility start-up and routine commercial manufacturing from small scale and large scale media preparation, vial thaw, through typical scale up processes, to seed and production bioreactors, with harvest and clarification technologies respectively. The Technical Specialist will be responsible for providing support for technology transfer of new/existing drug substance (DS) manufacturing processes to the Dublin facility, and will be required to work in close collaboration with Process Development, Operations, Engineering, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility startup and process qualification. The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, Technology Transfer, supporting start-up studies, building process data packs and performing process monitoring, study protocol generation, execution and report writing.

Responsibilities:

  • To provide technical process support in the area of media preparation, large scale cell culture bulk drug substance manufacturing process (vial thaw, scale up, seed reactors and production bioreactors) to support the successful startup
  • Working knowledge of typical cell culture unit operations, cause and effect, collation of data and trends. Performing process monitoring/trending.
  • To author and review process supporting documentation, gap assessments, technical protocols and reports, process validation documentation, strategy documents.
  • To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Material updates, material specifications.
  • To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines.
  • Partner with Operations to support protocol completion, execution and sample reconciliation.
  • To generate documentation reports for plant supporting studies and technical studies on the manufacturing floor at commercial scale.
  • May be required to work periodically out of normal business hours (temporary shift working) during periods of engineering and validation batch execution, as well as any other duties as required.
  • To provide on the floor support for troubleshooting processing issues and to participate in closeout of manufacturing investigations into process deviations and resolution.
  • Lead any key process changes using change control management system as required.
  • Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits.
  • Ensure compliance with site EHS policy, cGMP and other business regulations and participate in audits and incident investigations.

Minimum Qualifications and Experience:

  • Minimum requirement would be B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering. A higher degree (M.Sc. or Ph.D.) would be an advantage
  • Minimum 1-2 years’ experience in Technical Services / Process Development / Manufacturing Support in a biological bulk drug substance manufacturing organization.
  • Technical and operational knowledge of multiple unit operations in upstream processing, including media preparation, mammalian cell culture, centrifugation & depth filtration.
  • Understanding of technology transfer, scale-up process and cleaning verification/validation is advantageous.
  • Understanding of cGMP requirements for commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.
  • Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings.
  • Ability to present and defend technical and scientific approaches in both written and verbal form.
  • Ability to drive for results independently and adapt to rapidly changing priorities.
  • Detail orientated.
  • Technical writing competency.
  • Self-driven to do the right thing.
  • Enjoy a fast paced working environment with broad levels of engagement and insight for self-development and experience gain in a startup environment.

Document Coordinator – Dublin

Purpose:

Temporary role to support the coordination of documentation control activities for a major quality project

Responsibilities:

  • Assessment, coordination and withdrawal of documents within the Electronic Document Management System (eDMS)
  • Collaboration with document owners to facilitate efficient processing of impacted documentation
  • Generation of queries and reports from eDMS
  • Interface between Document Control and Training Operations to ensure updated documents are transitioned into the Learning Management System (LMS)
  • Generation, development and communication of project metrics and status update

Minimum Qualifications and Experience:

  • B.Sc. in science/engineering with a minimum of 3-5 years’ experience in cGMP Quality environment; or equivalent combination of education and experience
  • 3-5 years’ experience within the pharma industry or related field
  • Knowledge of cGMP requirements for documentation control
  • Direct experience with firstDoc eDMS or similar Documentum-based platform
  • High level of organization required to plan, execute and track completion of project deliverables
  • Excellent accuracy and attention to detail
  • Excellent communication and interpersonal skills

Project Validation Engineer - Waterford City

Purpose:

The role primarily involves (but not limited too) the installation and validation of Purified Water (CEDI unit) and Chiller Systems. The Project Engineer will have overall responsibility for planning, implementing and validating engineering projects and tasks, ensuring they comply with Pharmaceutical GMP quality standards.

Responsibilities:

  • The Project Engineer will be responsible for all aspects of a project life cycle from initial planning, through implementation and onto final validation (URS/FDS/IQ/OQ/PQ).
  • The Engineers primary focus will be on delivering projects that are on time and within budget. The projects must comply with all quality, pharmacopeia and ISO regulatory requirements.
  • It is also expected that the Project Engineer will manage internal stakeholders and external contractors that are required for the successful execution of all project tasks
  • The Engineer will ensure that all projects are maintained within budgetary control and comply with all Engineering, Quality and External regulatory requirements.
  • The role will involve managing electronic quality and training systems and any related metrics
  • The job holder will be responsible for liaising with manufacturing and laboratory management to plan and prioritise activities, with the aim of minimising interruptions in these areas
  • The role will involve ensuring that all projects are risk assessed, are subjected to good change control and validation practices and are impact assessed where appropriate
  • The Engineer will be responsible for updating and maintaining system drawings and standard operating procedures
  • The position will require that high levels of Health and Safety practices are adopted and maintained at all times

Minimum Qualifications and Experience:

  • Degree in mechanical engineering or an equivalent engineering discipline
  • Minimum of 5 years’ experience in a similar medical Device/Pharmaceutical role
  • Must be self-motivated, with ability to work on own initiative and prioritize
  • Must have experience of team working and excellent communication skills with the ability to motivate and influence people and drive corrective actions when necessary
  • High attention to detail
  • Proficient in problem solving and resolution
  • Excellent Communication Skills

Project Systems Lead – Operational Excellence - Waterford City

Responsibilities:

  • Engage in managing site strategic prioritization activities aligned to the site strategic roadmap
  • Define, Develop and implement a Site level CIP structured System to best in class industry standards that leverages quality, customer service and operational cost metrics to understand cost drivers and identify CIP and Cost of Quality opportunities
  • To enable a structured process that aligns to the annual Strategy and Budget Cycle that develops prioritized CIP’s and a process of ensuring a pipe line of Live, Candidate and completed projects.
  • To enable structured monthly reviews of project performance to ensure delivery of CIP goals, with a forward view of activity
  • Ensure Site management understands state of the business, cost drivers and CIP opportunities and that Project savings and expenses are tracked for every active project
  • Own, Develop and Manage the Site Strategic Space planning process with a 3 year forward view, to ensure that space requirements align to site strategies together with current and future customer demands. For both manufacturing and support functions
  • To ensure analysis of all site resources are reviewed and forecasted to support future customer demands
  • Focusing on Current space layouts, new product introduction and transfer requirements, developing optimized factory of the future layouts
  • Facilitate a quarterly review process of space transition that ensures SLT approval and sign off.
  • Use Problem Solving, Six Sigma and Lean tools & techniques to analyze business processes and identify project opportunities
  • Complete process reviews to identify process bottlenecks and capacity constraints, identify and implement ways to eliminate.
  • Act as change lead and key member of team implementing Process excellence strategy for the site.
  • Support process excellence & change management projects in implementing best in class methodologies and management systems e.g. Standard problem solving, Visual factory etc.
  • Ensure all improvement activities are aligned with quality and completed with a compliance Focus.
  • Generate rationale and associated statistical analysis to support proposed process improvements.

Minimum Education & Experience:

  • 3-5 years’ experience working in Procurement in Healthcare industry & experience working in a regulated environment
  • Strong Operational and Engineering experience
  • Strong technical competence and comprehensive understanding of manufacturing technologies in a high volume regulated environment
  • Project Management experience at a senior level
  • Third level qualification in science or engineering
  • Self-directed and highly motivated with the ability to prioritize and make decisions.
  • Experience with execution of LEAN and/or Six Sigma process
  • Experience in contributing to a lean transformation/change management
  • Knowledge of advanced statistical tools and experience in analyzing process performance based on data.
  • Experience in managing/developing people and influencing different levels of management
  • Strong personal accountability for project throughout its lifecycle.

ERP Analyst & System Administrator - Waterford City

Responsibilities:

  • The ERP Analyst & Systems Administrator will be responsible for application development and support, primarily for Business Systems to support the financial, procurement and distribution systems of the Contact Lens and Pharmaceutical Plant in Waterford. The successful candidate will play a key role in the implementation and subsequent support of SAP. They will also act as system and security administrator for Compliance Wire, Documentum (D2), FTIR, Empower, Eurotherm, UV, TOC, BMS, PDM and others.
  • Local application support of the Business in their utilization of the Global ERP/SAP application
  • Support and maintain of software within the ERP/SAP application to support Finance, Procurement, Engineering Stores, Raw Materials, Goods Inwards, Planning, Inventory Management and Distribution
  • Comply with Plant, Corporate policies for software development and validation
  • Ensure department staff are compliant with training requirements

Minimum Qualifications and Experience:

  • NFQ level 8 qualification (or equivalent) in IT related field.
  • 5+ years working in an analytical role
  • SAP development experience essential
  • IBM system-i, RPG(LE), CL(LE), SQL experience preferable
  • Working knowledge of ERP systems (BPCS) highly desirable
  • Excellent communication and presentation skills
  • Exemplary organisational skills with a keen eye for detail
  • Ability to work in a team environment

Senior Manufacturing Engineer - Waterford City

Purpose:

The Senior Manufacturing Engineer is a highly technical role required to support, debug and improve complex automation systems.

Responsibilities:

  • Develop \ design and implement cost justified process and equipment improvements with minimal

impact to production operating under 24/7 environment

  • Identify and eliminate repetitious machine failures
  • Provide consultative support to the Manufacturing and Maintenance groups
  • Utilise Lean Six Sigma tools and data to drive continuous improvement
  • Develop and Implement Safety and Quality improvements
  • Develop methods to ensure personnel engaged in operations\maintenance activities have sufficient knowledge to perform their assigned tasks
  • Prepare design specifications and associated documentation for equipment and system upgrades
  • Fault-finding \ troubleshooting of equipment and process issues
  • Installation, Commissioning and Validation of automation lines
  • Implement improvements under change control
  • Develop Functional and Detailed Design Specifications from formal and informal User Requirement Specifications
  • Be familiar with 21 CFR part 820 guidelines
  • Present, where appropriate, technical data to internal/external audit and inspection groups
  • Ensure Health and Safety Regulations and Procedure are adhered to at all times for self and others

Minimum Qualifications and Experience:

  • Bachelors Degree in Engineering (mechanical \ electronic) preferred
  • A minimum of 4 years in technical role in high volume manufacturing environment
  • Solidworks experience preferred
  • Six sigma experience preferred
  • Good problem solving abilities – able to identify facts, consider alternative approaches and evaluate the most appropriate action
  • Medical device and/or pharmaceutical industry experience preferred
  • Experience working in a validated environment with strong discipline with regard to change control is preferred

Quality Control Micro Analyst - Dublin

Description:

The QC Microbiology Analyst will support the Bulk Drug Facility in Dublin with emphasis on microbiological testing such as Environmental Monitoring, Water, Gas and raw materials sampling and testing, Bioburden and Endotoxin, technical support with regard to method validation, regulatory updates and new technology.

Responsibilities:

  • Environmental and Facilities monitoring sampling and testing.
  • Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements.
  • Validation/Qualification of Microbiology test methods and test systems such as the Endotoxin test system and Identification system.
  • Represent the Microbiology department in internal and external audits where appropriate.
  • Close out of actions/ recommendations identified from both internal and external audits.
  • Assist in ensuring that current compliance issues and trends, both internal and site-wide, are critically evaluated and training is provided where appropriate
  • To maintain competence and keep up to date with all new technologies, procedures and methods used in the Microbiology Laboratory.
  • Perform technical review of data generated in laboratory, validation protocols and reports.
  • Provide Technical support to Manufacturing and Projects which the company undertakes through project participation, investigation, validation and testing activities and prepare Technical Reports as required.
  • To ensure all instruments/equipment are maintained in a calibrated and operational state.
  • To ensure a high standard of housekeeping and safety is maintained in the Laboratory.
  • Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.
  • To keep management updated on issues arising within the laboratory.
  • Scheduling of testing, review and authorization of microbial data.
  • Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Microbiology Laboratory Supervisor, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time.
  • To train laboratory personnel and play appropriate role in the development, operation and evaluation of training/re-training programs.
  • Any other duties as required by management.

Minimum Qualifications and Experience:

  • Degree in Microbiology or related science.
  • Minimum of 1 year experience in cGMP Quality environment.
  • Experience in testing of sterile drug product and aseptic filling process of sterile pharmaceutical /biopharmaceutical products.
  • Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of c GMP operations supporting clinical and commercial manufacturing.

Competencies:

  • Technical competency in Sterility Assurance, Aseptic filling and microbiology methods.
  • Ability to develop collaborative relationships with other functions and sites in order to achieve functional, site and company goals.
  • Problem solving and root cause analysis skills.
  • Organizational skills.
  • Planning/scheduling of own work and subordinates and ability to delegate tasks where appropriate.
  • Excellent written and oral communication skills.

Formulation Scientist – Waterford City

Responsibilities:

  • Project Planning:
    • Together with the Formulation Development Manager and Formulation Development Team Lead, actively plan on-going formulation development requirements; ensuring major milestone targets for each project are visible to all team members and key stakeholders to achieve on time market entry.
    • Together with the Formulation Development Manager and Formulation Development Team Lead, determine tasks required to deliver each project milestone by breaking them down into tasks; identify equipment, materials and people needed.
    • Proactively build effective working relationships with Core Team and Functional Members.
  • Compliance:
    • To ensure that work carried out is in compliance with required standards conforming to company, cGxP, SOPs, regulatory regulations & guidelines, Health, 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. Highlight opportunities for system optimisation to team members.
    • To support all on-going formulation and regulatory functions & requirements.
    • To complete all documentation correctly in order to achieve a high level of customer satisfaction and compliance to GMP.
    • To prepare reports and submission documentation in support of licence applications to various regulatory authorities.
    • To perform additional team tasks as agreed to support effective running of the Business
  • Health & Safety
    • Ensure requirements of company Safety Statement are implemented
    • Continuously promote a positive safety culture by leading by example
    • 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 Pharmaceutical science or related discipline.
    • At least five years’ experience working in a formulation development, process development, manufacturing or related technical environment.
    • Pre-formulation experience, including drug characterisation and ingredients selection.
    • Formulation studies, considering such factors as particle size, polymorphism, pH and solubility, as all can influence bioavailability and drug activity.
    • Process optimisation and scale up experience are essential
    • Analytical/ laboratory experience would be advantageous.
    • Have demonstrated effective research skills, including the critical review of the scientific literature.
    • Knowledge of all drug product manufacturing processes is essential.
    • Fill Finish and Dry Powder Inhalation (DPI) experience is advantageous.

Formulation Development Team Lead

Responsibilities:

  • To coordinate and lead all R&D and Operations related formulation development activities and to ensure strict adherence project plans
  • To perform all activities required to ensure that all R&D project milestones are delivered according to agreed timelines.
  • To work closely with PMO to ensure all work stream leads are appointed to all ongoing projects and all planned tasks are being progressed.
  • Apply a thorough knowledge of pharmaceutics to the development of drug products and the interpretation of in-vitro data to predict in-vivo performance.
  • Interpret in-vivo data for the purposes of further formulation development.
  • Communication of project data through presentations at internal meetings and through formulation development reports.
  • Provide guidance and lead pivotal scale cGMP exhibit batch manufacture based upon a sound knowledge of site and departmental SOPs, and an understanding of ICH/FDA/EMEA requirements as they relate to formulation and process development activities.
  • Maintain a comprehensive knowledge of formulations and process development disciplines through research and scientific literature.
  • Identify, assess, recommend and implement internal and external opportunities to broaden EirGen Pharma’s technical/scientific capability.
  • Project Planning:
    • Actively plan on-going formulation development requirements; ensuring major milestone targets for each project are visible to all team members and key stakeholders to achieve on time market entry.
    • Determine tasks and resources required to deliver each project milestone by breaking them down into tasks; identify equipment, materials and people needed.
    • Proactively build effective working relationships with Core Team and Functional Members.
  • Compliance:
    • To ensure that work carried out is in compliance with required standards conforming to company, cGxP, SOPs, regulatory regulations & guidelines, safety and environmental guidelines. 
    • Initiate action to correct quality/schedule problems or notify others of quality issues as appropriate. If a procedure does not exist, devise one; if a process needs amending, do so.
    • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement. Highlight opportunities for system optimisation to team members.
    • To support all on-going formulation and regulatory functions & requirements.
    • To complete all documentation correctly in order to achieve a high level of customer satisfaction and cGMP. 
    • To prepare pharmaceutical development reports and submission documentation in support of licence applications to various regulatory authorities.
    • To perform additional team tasks as agreed to support effective running of the Business.
  • Health & Safety
    • Ensure requirements of EirGen Safety Statement are implemented
    • Continuously promote a positive safety culture by leading by example
    • 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 honours degree level in Pharmaceutical science or related discipline. Master’s degree would be advantageous
  • At least five years’ experience working in a formulation development, or related technical environment
  • Experience in effectively operating both GMP and Non-GMP areas
  • Pre-formulation experience, including drug characterisation and ingredients selection
  • Formulation studies, considering such factors as particle size, polymorphisms, pH and solubility, as all can influence bioavailability and drug activity
  • Supervisory/ management experience essential
  • Analytical/ laboratory experience would be advantageous
  • Project management and team leadership skills are essential
  • Have demonstrated effective research skills, including the critical review of the scientific literature

QC Chemist – Fill Finish – Waterford City

Purpose:

To support Product Development, Clinical Supply and launch of Parenteral Products. To Support Fill Finish Quality related tasks.

Responsibilities:

  • To draft/ review test methods.
  • To take part in laboratory and operation investigations as required.
  • To liase directly with customers and contract laboratories and attend conference calls as required.
  • To attend internal project review meetings as required.
  • To assist in the preparation for customer/ regulatory inspections. 
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • To ensure that all work is carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • To complete all documentation correctly, in line with data integrity guidelines, free from errors, omissions or defects in order to achieve a high level of customer service and cGMP. To peer review documentation as required.
  • To perform additional team tasks as agreed to support effective running of the Business.
  • To support all other on-going laboratory functions & requirements.
  • To perform AQLs as required on Raw Material and Finished Products.
  • To perform inspection of Stability and Retention samples as required.
  • To support Fill Finish with Foreign matter investigations. (Identity, trending and Investigations)
  • Health and Safety
    • To ensure the requirements of EirGen’s Safety Statement are implemented.
    • To continuously promote a positive safety culture by leading by example.
    • To implement safety requirements as per site documentation including SOP’s, Safety Statement and COP’s.
    • To report any defects/hazards

Minimum Qualifications and Experience:

  • Qualified to a minimum of degree level in chemistry, pharmaceutical science or a related discipline
  • Strong analytical ability.
  • Strong quality orientation.
  • Good time management.
  • Strong attention to detail.
  • Good problem solving abilities.
  • Excellent organisational skills.
  • Ability to multitask and work under pressure, coping with more than one conflicting task at once.
  • Excellent communication skills, both verbal & written.
  • Adaptability – ability to maintain effectiveness in varying environments and with different tasks, responsibilities and people
  • Ability to work effectively with a team to accomplish organisational goals
  • Proficient in the use of electronic document management systems.
  • Proficient in Technical report writing
  • Strong Safety awareness.
  • Knowledge & proficiency of Microsoft products for example MS Excel, Word & Project, Power-point.

QA Officer – Waterford City

Purpose:

The main purpose of the role is to support manufacturing areas with QA support including but not limited to the following:

  1. Real time in situ batch documentation review

  2. Real time assessment of manufacturing events from a QA perspective.

  3. Provide clearance to precede instructions in manufacturing following unplanned events. 

Minimum Qualifications and Experience:

  • A third level degree incorporating Quality Assurance/ Management.
  • Have minimum 2 years relevant experience in a Pharma role / GMP related role.
  • Experience with desktop and internet-based software applications (e.g. electronic document management system, MRP system) an advantage but not essential.
  • Excellent communication and presentation skills
  • Focus on quality and detail
  • Careful planning to achieve accurate and timely result
  • Ability to define and manage own tasks and schedules
  • Experience performing and assessing risk/impact assessment an advantage

Warehouse Associate - Dublin

Description:

The Warehouse Operator is responsible for the day to day warehouse activities at the Dublin facility. They are responsible for ensuring that all warehouse activities are completed as per approved Standard Operating Procedures (SOP’s), in a safe manner and in compliance with current Good Manufacturing Practices (cGMP). The individual in this position is expected to represent the companies Pharmaceutical interests, objectives and policies in a professional and responsible manner.

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
  • Carry out dispensing activities in a controlled environment
  • 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.
  • 2-5 years’ experience performing Warehouse support activities preferably in a cGMP commercial manufacturing environment.
  • Previous experience with dispensing activities preferred
  • 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