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

QA Documentation II - Dublin

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 updates.

 

Minimum Qualifications and Experience:

  • 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.

 

Supply Chain Distribution Specialist - Dublin

Responsibilities:

  • Coordination and execution of Finished Packed Product shipments across the company’s Global Network
  • Manage operational logistics to identify, develop, update or maintain sustainable processes to ensure on-time delivery with no interruption to supply across the company’s Global Network
  • Support the supply chain product security network, with responsibility to develop processes
  • Primary contact for stakeholder engagement with the company’s Global Trade function to ensure compliance in import/export processes
  • Manage aspects of the daily compliance requirement which will include the oversight of the quality records metrics
  • Creation of GMP and non-GMP documentation including procedures, specifications and shipping documentation across Global Logistics
  • Primary training representative for Global Logistics
  • Responsible for CAPA’s, Change Controls & Deviations program and initiate Corrective Action plans in the company’s Quality Management System, TrackWise
  • Fully compliant with internal SOP’s, standards and associated training.
  • Identify process improvements within the function and drive the initiative forward to implementation and effectivity
  • Participate and manage 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 ensure efficient execution of schedules.

Minimum Qualifications and Experience:

  • Degree in Business Management, Supply Chain/Logistics, or related field preferable
  • At least 5 years’ working in Pharmaceutical supply chain distribution operations management activity within an international environment is essential
  • Knowledge and understanding of GMP/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.

 

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.

 

Technical Specialist - Dublin

Purpose:

The Purification (Downstream) Technical Specialist has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS) as part of the Technical Services Team at the company’s facility in Dublin. The Technical Specialist will provide protein purification processing expertise to support the facility design, start-up and routine commercial manufacturing for chromatography, UFDF/TFF filtration, Viral filtration technologies and bulk fill unit operations 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, DS Process Sending unit, Operations, Engineering, Supply Chain, Quality, Quality Control, Regulatory and other involved departments to ensure successful facility start-up and process qualification (PPQ). The position is accountable for timely completion of technical transfer related milestones, with particular emphasis on new product introduction, Process Owner for purification unit operations, Process Validation (PPQ), Process Monitoring, Risk Assessment (using QRM tools), and building strategies / SME capability.

 

Responsibilities:

  • To provide process expertise in the area of buffer preparation, large scale protein purification drug substance manufacturing process (column chromatography, VI, UFDF/TFF, Viral filtration and bulk fill) to support the successful startup of the company’s BDS facility in Dublin.
  • Working knowledge of typical chromatography and filtration unit operations and functional purpose, cause and effect, in-process tests, and mass balance principles.
  • To author and review process transfer documentation, gap assessments, technical protocols and reports, including process validation documentation & strategy documents.
  • To identify requirements for laboratory studies to support process fit, decisions or process transfer, and to liaise closely with Global Process Development to input to the design/ execution of studies.
  • To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements.
  • 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.
  • To identify and implement process and continual improvements; e.g. yield, cycle time reduction etc.
  • To generate documentation protocols and lead the execution of 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 required, and participation in on-call roster.
  • To provide on the floor support for troubleshooting processing issues and to lead manufacturing investigations into process deviations and resolution with CAPAs.
  • Lead any key process changes using change control management system.
  • 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 risk assessments, audits and incident investigations.
  • To author and review IND, BLA and other technical documents for regulatory agency submissions.
  • To serve as a subject-matter expert (SME) on technology transfer and process unit operations support during regulatory agency inspections.

 

Minimum Qualifications and Experience:

  • Minimum requirement would be B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or Eng. Process or Chemical Engineering. A higher degree (M.Sc. or Ph.D.) would be an advantage
  • Minimum 5 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 downstream protein purification processing (chromatography, filtration, TFF).
  • In-depth technical and operational knowledge of multiple unit operations in downstream processing, including buffer preparation, industrial scale protein purification, TFF filtration, final fill, nano and process filtration.
  • Strong understanding of technology transfer, scale-up process and cleaning validation.
  • Comprehensive understanding of cGMP requirements for clinical and commercial biopharmaceutical manufacturing and the ability to implement best practices to ensure multi-product bulk drug manufacturing operations are cGMP compliant.
  • Experience of Validation / Verification of GMP equipment or processes would be beneficial.
  • Experience of design, commissioning and start-up of a bulk drug substance facility would be beneficial.
  • 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
  • Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing.
  • Technical writing competency.
  • Experience of authoring CMC sections to support regulatory submissions would be advantageous.
  • Experience of Technology Transfer activities is advantageous.
  • Experience of disposable technology would be advantageous.
  • Knowledge or experience of start-up or systems would be ideal.

 

Quality Control Micro Analyst - Dublin

Purpose:

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. This position will work on a shift schedule.

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:

  • Minimum of 1 year experience in cGMP Quality environment.
  • Degree in Microbiology or related science.
  • 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 cGMP operations supporting clinical and commercial manufacturing.
  • 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.

 

Buyer - Waterford City

Purpose:

Ensure all Purchase Orders are raised and sent to the supplier in a timely manner. Ensure compliance with all relevant Customs Procedures Day to day procurement/administration activities required to support the Department.

Responsibilities:

  • Ensure all Purchase Orders are reviewed for accuracy and compliance and are sent out in a timely manner
  • Expedite Purchase Orders where required
  • Raise Capital and Indirect Purchase Orders.
  • Raise Special Payment Requests
  • Vendor Management including negotiating pricing with vendors
  • Issue RFQ packages and analyze tender returns
  • Prepare and obtain approval for the set-up of all New Suppliers
  • Monitor all Imports and check paper work on a monthly basis
  • Advise Customs Clearing Agent of any errors & provide classification clarifications when required to our Clearing Agent
  • Run weekly SOX and PO Amendments Reports
  • Manage the Mobile Phone A/C. Manage the introduction of all new handsets and the setting up of new accounts with the Mobile network
  • Ensure SOP’s and Work Instructions are updated in Documentum
  • Ensure Compliance Wire is up to date
  • Prepare and support the Contract approval process
  • Support / Backfill other Procurement activities as required

 

Minimum Qualifications and Experience:

  • Over 3-5 years’ experience working in Procurement in Healthcare industry
  • MRP experience
  • Knowledge of ERPLx is desirable
  • Excellent interpersonal, communication, influence and negotiation skills
  • Demonstrates strong attention to detail, sound judgment and ability to work on own initiative
  • Proficient in problem solving and demonstrate financial acumen

 

Senior Quality Systems Engineer - Waterford City

Purpose:

The primary function of the Senior Quality Systems Engineer is to provide support to the MDR team and ensure all required objectives associated with 2017/745 (MDR) are implemented in the manufacturing plant.

Responsibilities:

  • Assist with the maintenance of the Quality System within the plant
  • Management of metrics on change control, CAPA etc
  • Drive improvement and efficiency within the quality system
  • Implement any Plant Quality system changes as identified by MDR
  • Provide Supplier Quality support to any supplier changes / material changes
  • Work closely with the plant ensuring clear communication of any new Regulations
  • Support risk management, risk analysis and health hazard analysis
  • Assist in the internal audit Programme, preparing metrics and analysis of results following audits
  • Work cross functionally to drive robust corrective actions based on thorough review of complaint data
  • Additional requirements of the job will be specified by the Quality Systems Manage

 

Minimum Qualifications and Experience:

  • 3rd level Qualification in Quality / Science / Engineering with a minimum of 5 years work experience in a Quality Systems Engineering role
  • Experience working with an ISO13485:2016 compliant quality system essential
  • Operational Excellence Training advantageous
  • Self-directed and results driven team player.
  • Ability to work on own initiative, to deadlines, while also capable of working as part of a multi discipline team
  • Strong problem-solving skills and ability to handle multiple tasks in a fast paced environment
  • Excellent interpersonal and communication skills, both written and oral with the ability to work effectively with staff at all levels of the organization
  • Excellent organisational skills, ability to take on and drive a project

 

Reliability Technician - Dublin

Purpose:

Our client is looking to hire a reliability technician with a mechanical / electrical craftsperson trade with at least 4-5 years’ experience working in tube filling and packaging or similar to join their team in Dublin. The Process Engineering team are responsible for process improvements, by minimising waste and variation in our processes, in order to improve efficiency, reduce cost and maximise profitability within the filling and packaging business unit function.

Responsibilities:

  • Implement mechanical / electronic improvements on the filling and packaging lines Assist in process mapping and risk assessing of equipment and processes
  • Improve equipment availability % by understanding failure modes of the equipment and putting strong corrective and preventative measures in place to ensure the failures are eliminated / minimised
  • Assist in the technical writing of SOPs and Work Instructions to ensure the correct processes are in place and followed
  • Assist with the creation of training packages on the use and maintenance of equipment.
  • To work closely with the equipment manufacturers to ensure the correct procedures are in place for the lifecycle of the equipment.
  • Assist with equipment purchasing through the use of equipment commissioning processes
  • Partake in technical and feasibility studies
  • To think both creatively and logically to resolve process problems using Lean Six Sigma methodologies
  • To liaise with cross functional groups to improve processes, equipment usage in order to improve overall OEE

Minimum Qualifications and Experience:

  • Experience as a craftsperson / fitter, preferably in tube manufacturing (Filling and Packaging)
  • Analytical thinker with good interpersonal skills
  • Strong communication skills and ability to influence stakeholders and work closely with them to determine acceptable solutions
  • Proficiency in Microsoft tools; excel, word
  • Ability to work creatively and analytically in a problem-solving environment
  • Experience in the use of equipment risk assessments

 

Project Engineer - Dublin

Purpose:

A vacancy exists for a P5 Project Engineer within the Technical Services Department. Reporting to Engineer Project Manager. You will be working within cross-functional teams with a high-level of autonomy; playing a key role in Schedule Preparation, Pre-Planning and Resource Forecasting along with Project Management of Opex and Capex Projects on site.

Responsibilities:

  • To lead projects taking the role of Engineering Team Leader, from project registration right through to validation/commissioning and hand over, as per Engineering SOP for ‘Project Management’ ensuring that projects are completed to specification, within budget and on programme.
  • To liaise with the project requester and define exactly the project brief.
  • To liaise with customer department as well as other Business Unit departments and support departments as required such as EHS, Tech Services, and Logistics etc.
  • To attend regular planning meetings as required to ensure plant downtime is agreed.
  • To make justifiable decisions at all times which will not compromise quality, capacity, flexibility, operability, security or EHS compliance.
  • To immediately report to the Engineer Project Manager any deviations from the project plan which would have an impact on quality, specification, programme or cost .
  • To ensure that adequate training is provided to Production and Engineering personnel, and to assist in any way that is practical.
  • Chairing of design review meetings, site meetings, haz-ops, project meetings etc.
  • To ensure that Project are handled and managed using the ’team’ approach.
  • Ensuring that the Engineer in particular and the Department as a team are kept up to date in current engineering technology and work practices by attending, with approval, relevant seminars, exhibitions, training/educational courses and by reading engineering literature.
  • To follow up snags ensuring that the project is completed fully, before closing the Capital Account.
  • To communicate effectively within the Department Function and particularly with the customer.
  • Ensure that all procedures described in the Department SOP’s or WI’s and Guidelines are strictly adhered to.
  • To ensure that plant hand over, including the preparation of documentation packages is carried out in a controlled and punctual manner as per company procedures.
  • To plan, manage, co-ordinate and design the ’front-end’ design of the project whilst evaluating quality and value relative to practicalities.
  • Preparation of equipment specifications, budget estimates, scope documents, IA submittals, purchase requisitions, cost control data sheets, meeting minutes and circulation of same.
  • To prepare installation specifications as per Standard Procedures and to complete AWP’s for all work.
  • To oversee and control CAD services to ensure drawings are registered, prepared, checked, approved, circulated and controlled as per SOP for ’Registration and Control of Engineering Drawings’.
  • To act as safety lead in line with construction regulations 2013 and appoint PSDP and / or PSCS as required. Also, to ensure EHS risk assessment carried out and actioned prior to capital submittal.
  • To liaise with appointed external consultancy practices as directed, ensuring that the consultant operates to company procedures within a team framework.
  • To source, select, procure, inspect, approve and oversee installation of equipment, machines and systems.
  • To ensure that current regulations, standards and work practices are adhered to for all project work, i.e. FDA, HSA, HPRA, EPA, British Standards, USP, ETCI etc.
  • For engineers managing direct impact projects they must carry out the commissioning and qualification phases as per SOP_002492.
  • To liaise with Q.A Compliance ensuring that regulatory and validation issues have been addressed in an approved manner.
  • To follow up on qualification deviations.
  • To manage and control contractors working on company site, ensuring that work practices comply with the relevant sections of the 2013 Construction regulations, company Standards and cGMP.
  • To ensure decisions, work practices or use of certain contractors do not expose the company to the risk of an industrial dispute.
  • To ensure that training records are adequate and kept up to date.
  • Ensure that change control procedures are strictly adhered to.

Additional Duties:

  • Sterile Processing – Bulk and Filling Operations
  • Good understanding of sterility requirements/environmental monitoring requirements
  • Grade A/B environment/exposure
  • Good understanding of aseptic techniques and technology
  • Cleaning Validation CIP/SIP (Stem in place)
  • Media batch experience/incubation
  • Understandings of Autoclave technology
  • Strong documentation skills
  • Good Understanding of Regulatory requirements
  • Audit Experience.

 

Minimum Qualifications and Experience:

  • 3rd Level Qualification in an Engineering discipline
  • For Engineers working on ‘Direct-Impact’ projects, they should have minimum 3 years pharma experience, and 5 years total experience.
  • For Engineers working on ‘Indirect – Impact’ projects, they should have minimum 5 years’ experience.

 

Training and Development Specialist - Waterford City

Purpose:

Working within the HR team, support the Training & Development function ensuring compliance to Learning and Development strategy and requirements across the company’s facility.

Responsibilities:

  • Work as part of the project team to implement, maintain and update the Learning Management System – company LMS
  • System administrator for company LMS
  • Provide ongoing Training support to all areas across the company Campus to ensure compliance to all training and development procedures.
  • Support Area Managers and Team Leads in completing team Individual Training Plans via the Training & Development Process Map
  • Support HR with the Induction training program and carry out training of new employees as appropriate.
  • Support the identification of the campus training needs and co-ordinate the sourcing of approved course aligned to the campus training plan
  • Co-ordinate and support the Leadership Development Programme
  • Liaise with Area Managers & team leaders to continuously improve the training system and ensure they can directly address the development of their direct reports
  • Work with all departments/functions where relevant to support the development of competency-based profiles, training matrices and on the job certifications.
  • Support the completion of all relevant documentation to comply with training & development grant reporting requirements
  • Ensure all new starters / internal movers / graduates have a training plan identified ready for them commencing their new role
  • Design and deliver Training Courses in line with business needs
  • Author/review and approve Learning documentation/material
  • Develop training effectiveness indicators to monitor progress as well as differences between operational areas
  • Ensure effective communication and promotion of training and development activities
  • Identify, support and implement continuous improvement initiatives or projects.
  • Ensure timeliness of CAPA and audit actions
  • Work with Training & Development Controller to set up training, raise vendor PO’s, system administration for EQi etc
  • Participate as part of the HR team including adhoc projects, event management HR & training initiatives, HR communication etc

Minimum Qualifications and Experience:

  • At least 3 years previous experience in a training & development function within a pharma/ manufacturing/R&D environment
  • Extensive Learning Management System experience, preferably Success Factors
  • Significant experience in supporting managers in training & development related requirements
  • Experience in use of training & development tools and systems
  • Computer literate

 

Senior Project Engineer - Dublin

Purpose:

A vacancy exists for a P4 Senior Project Engineer within the Technical Services Department in our client’s Dublin facility. You will be working on one main high priority CapEx project within cross- functional teams with a high- level of autonomy; playing a key role in Schedule Preparation, Pre- Planning and Resource Forecasting along with Project Management of Opex.

Responsibilities:

  • To lead the project taking the key role of Engineering Team Leader, from project registration right through to validation/commissioning and hand over, as per Engineering SOP for ‘Project Management’ ensuring that projects are completed to specification, within budget and on programme.
  • Manage and co-ordinate the necessary resources to ensure effective execution of the design, costing, programming, installation and validation phases of all major capital projects.
  • Following a project installation phase, implement the Plant hand back procedures by paying attention to engineering commissioning, check-lists and follow-up. Provide an Engineering C&Q function to the company.
  • Manage and co-ordinate the necessary resources to ensure effective execution of the design, costing, programming, installation and validation phases of this major capital project.
  • Monitor contractors to ensure the company gets value for money and contractors are of the highest quality.
  • Initiation and preparation of project related plans, schedules, reports, feasibility studies, analysis, budget parameters. Prepare and maintain a regular project reporting format. Provide business cases, justifications and strategy input to major projects.
  • Ensure that the Project Department liaise effectively with all areas within Technical Services.
  • Motivation of staff to ensure procedures and design is of the highest standard.
  • Pay due care and attention to Health and Safety and Environmental issues.
  • Ensure that all companywide procedures are adhered to within the Department and Ensure that all documentation is following the Engineering Department Standards.
  • Liaise with the Department customers ensuring that their requirements are fully understood and that their expectations are met.
  • Ensure that all staff and contractors receive adequate training in relevant areas and that training is reviewed on an annual basis.
  • Ensure that all work carried out is to the highest standard and is in accordance with international and regulatory standards.
  • To manage and organise effectively with CapEx Manager the Project Managers required for the project from Technical Services Department.
  • Deliver the Project within budget and on time.
  • To provide strong leadership and coaching to all departmental personnel so that they actively support activities that improve performance.
  • To lead the Project with a proactive approach.

Minimum Qualifications and Experience:

  • Minimum 10 years’ experience in the Pharma industry, preferably in a management / supervisory role
  • Must have 3rd level Engineering qualification or equivalent Project Management/ Financial – Business qualification

 

Production Specialist - Dublin

Purpose:

A vacancy exists for a Production Specialist within the Production Support Department. Reporting to the Production Support Manager, your role will be part of a team responsible for a variety of key area’s within the production departments. You will be required to have a strong understanding of the compliance standards required in a pharmaceutical production environment. You will be working within cross-functional teams with a high-level of autonomy; playing a lead role in process investigations, identifying root cases and delivering process improvements.

Responsibilities:

  • Carrying out thorough and structured investigations into process issues
  • Proactively working on process improvements before issues occur
  • Leading and implementing change to key areas of production
  • Supporting the on time release of product as required
  • Act as the SME for production processes in cross functional teams/projects

Minimum Qualifications and Experience:

  • Third level qualification (NFQ Level 8 or higher) in Process Engineering or a relevant discipline
  • Minimum of 5 years relevant experience within the Pharmaceutical industry
  • Broad ranging process improvement based experience & problem solving abilities
  • Knowledge of bulk production, filling and packaging processes and techniques
  • Strong understanding of GMP and a right first time approach
  • Competency and experience in structured problem solving. Lean six sigma certified to a Green belt level or higher
  • A “ can do” attitude and genuine enthusiasm for driving improvements
  • A positive mindset of Safety First
  • A confident team player who can work with a high degree of autonomy.
  • Ability to engage and influence key internal stakeholders so that they can deliver on improved performance

 

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
  • 2-5 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

 

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.

 

Analyst - Shift - Shanbally

Purpose:

The primary purpose of these roles is to provide support to internal and external customers by providing quality testing, delivering results in accordance with GMP standards and ensuring products are safe for patient use and fit for purpose.

Responsibilities:

  • Perform TOC/Conductivity, Wet Chemistry and other Chemistry testing
  • Microbiological testing including Bioburden and Endotoxin testing
  • Perform primary review of QC raw data and trend results
  • Draft QC SOPs
  • Evaluate results against defined acceptance criteria
  • Conduct and document laboratory investigations to completion

Minimum Qualifications and Experience:

  • A degree in Microbiology, Chemistry or a related discipline is required with a minimum of 1 year within a pharmaceutical regulatory environment
  • Ability to work independently and meeting established timelines.
  • Knowledge of cGMPs
  • Excellent communication skills both written and verbal
  • Customer focus; takes personal responsibility for speed; quality and accuracy of delivery
  • Self-motivated and ability to work under pressure
  • Successful track record in achieving goals as part of a team within a growing, dynamic environment
  • Demonstrated adaptability and flexibility to support a growing organisation.
  • Please note that these roles will involve continental 12 hour shift work and a shift premium will be provided for this.

 

Biochemistry Analyst - Kinsale

Purpose:

This position is to support the Biochemistry team and will require analytical skills to troubleshoot laboratory issues. The position will involve CIEF testing, HPLC, CSDS testing and possibly Chemistry testing.

The Ideal Candidate Would Have:

  • Strong scientific and organisational skills
  • Excellent communication, both oral and written
  • Excellent attention to detail
  • Ability to work independently and as part of a team, with self-motivation, adaptability, and a positive attitude
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
  • Good working knowledge of cGMP
  • Authorisation to live and work in the Republic of Ireland indefinitely without restriction or sponsorship

 

Minimum Qualifications and Experience:

  • A 3rd level qualification in a scientific discipline
  • At least 1 years’ analytical laboratory experience in a GMP environment
  • A good knowledge of HPLC, Empower, Stability, SDS-Page, IEF, CE, plus general laboratory skills (balance, pipette, cleaning, equipment management etc.) is required
  • Experience with LIMS systems is desirable

 

Microbiology Analyst - Kinsale

The Ideal Candidate Would Have:

  • Microbiology In-Process and Final Product Testing (Bioburden/Endotoxin in particular)
  • Environmental Monitoring
  • Method Transfer/Validation (Bioburden/Endotoxin)
  • Water Utilities Testing
  • Method Updates/Report Writing (Micro)
  • Knowledge of LIMS and Trackwise would be a distinct advantage

 

Minimum Qualifications and Experience:

  • A degree in microbiology or a related subject
  • At least 18 months’ experience in a microbiology laboratory
  • At least 1 years’ experience in a GMP environment
  • Good team player, organised, accurate, have strong documentation skills
  • Flexible, adaptable to changing priorities
  • Passionate about quality and client service
  • Good communication skills both internally and externally
  • A flexible approach to changeable working patterns and be available for shift work should it be required

 

BDS Manufacturing Technologist - Dublin

Responsibilities:

  • Manufacturing Technologists are responsible for Manufacturing Support to the BDS operations in Dublin. They help to build and sustain employee engagement by creating a culture of open, efficient execution and an environment in which individuals and teams can excel and continuously improve.
  • The level 3 manufacturing technologist is a senior role, which requires significant subject matter expertise and provides technical leadership, leading complex projects relating to improvements and investigations within the BDS operations function.
  • Leader and provider of expert technical and documentation support to investigations, CAPA’s, change controls, training and improvement projects ensure the manufacture of bulk drug substance is performed in a safe, compliant, cost effective manner meeting the regulatory requirements defined in relevant health authority submissions, cGMPs and local Health and Safety requirements.
  • During the start-up project and routine new product introductions, the Manufacturing Support team provide end user operations requirements input into design, commissioning and validation of equipment, automation and processes as part of multi-function project teams.
  • The Manufacturing Support team takes a lead role developing Operations procedures, batch records (electronic or paper as required), other documentation and provide technical training to the Operations teams.
  • Manufacturing Technologists take an active role in setting up work practices and procedures that minimize human error, and work with operations continuous improvement teams to remove sources of error.
  • Manufacturing Technologists successfully lead teams to deliver all project requirements associated with cost, time and functionality, ensuring that all KPI targets are achieved.
  • The Manufacturing Support team Develop and maintain strong and effective relationships with partners at the facility including Quality, Engineering, Technical Services, Supply Chain, Regulatory Affairs, Human Resources and Finance. They lead and contribute to best practice sharing with manufacturing and technical colleagues at other company facilities and across the industry.

 

Minimum Qualifications and Experience:

  • Undergraduate degree in science or engineering or equivalent is required
  • A minimum of 8 years’ experience in Manufacturing Operations, Technical Support or Equipment Engineering in a biopharmaceutical company or closely aligned industry
  • Extensive knowledge of biological manufacturing processes
  • Significant experience with leading projects in areas such as media prep, buffer prep, sterile filtration, upstream and downstream unit operations. Experience of formulation, aseptic and sterile manufacturing, including, autoclaves, sterile filtration, Vial and Syringe packaging would be an added advantage
  • Experience of capacity expansion and new product introduction project work is essential and experience of a green field start-up is desirable
  • Experience in investigating complex manufacturing investigations, CAPA’s and Change Controls
  • Good knowledge of GMP/HPRA/FDA regulatory requirements and current Health and Safety Regulations legislation
  • Well-developed analytical, numerical and computer skills and the ability to combine hands-on activities with theoretical knowledge and expertise
  • Good Presenting and Training Skills
  • Good Technical writing skills
  • Excellent communications and decision-making skills
  • Min Green Belt in Lean six sigma
  • Proven ability to work well as part of a team & on own with minimum supervision
  • Proven leadership skills
  • Other duties as required

 

Release and Stability Chemist (R&D) - Waterford City

Purpose:

To analyse stability products to agreed schedules and in accordance with regulatory requirements. To assist other R&D groups in the testing of In Process and Finished Product samples if required.

Responsibilities:

  • To test submission stability products in a timely and efficient manner to agreed schedules and in accordance with Regulatory requirements.
  • To assist other R&D groups in the testing of In Process and Finished Products if required.
  • To review test methods and draft stability protocols as applicable.
  • To prepare submission documentation in support of license applications.
  • To take part in any laboratory investigations/troubleshooting.
  • To trend analytical data 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.
  • Health & Safety
  • To ensure the requirements of the company’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.
  • At least two years experience working in a related technical environment.

 

Document Controller - Dublin

Responsibilities:

  • FirstDoc Coordinator via EDMS System
  • Copy, scan and store documents via Sharepoint
  • Receipt of Vendor and Contractor Turnover Packages
  • Check for accuracy and edit project files
  • File documents in physical and electronic copies
  • Create templates for future use
  • Retrieve files as requested by employees and contractors
  • Manage the flow of documentation within the BDS Project
  • Issue Documentation numbers
  • Updating project procedures and fillable forms
  • Documentation turnover transfer care, custody and control
  • Prepare ad-hoc project reports as required
  • Audit preparation
  • Any other duties as required by management

 

Minimum Qualifications and Experience:

  • 3+ Years’ experience in a similar role is essential for this position
  • Educated to Leaving Certificate standard (or equivalent)
  • Proven work experience as a Document Controller or similar role
  • Familiarity with project management
  • Hands-on experience with MS Office and MS Excel
  • Knowledge of Electronic Document Management Systems (EDMS)
  • Proficient typing and editing skills
  • Data organization skills
  • Attention to detail
  • Well-developed analytical, numerical and computer skills and the ability to combine hands-on activities with theoretical knowledge and expertise
  • Good Presenting and Training Skills
  • Good Technical writing skills
  • Excellent communications and decision-making skills
  • Min Green Belt in Lean six sigma
  • Proven ability to work well as part of a team & on own with minimum supervision
  • Proven leadership skills
  • Other duties as required

 

CQV Engineer - Dublin

Purpose:

The CQV Engineer performs activities to support the validation activities of the companies cGMP manufacturing plant in Dublin, Ireland. This includes supporting validation actions for Packaging and Warehousing facility, and temperature mapping of various units / areas. The role is a contract position as part of the CQV team.

Responsibilities:

  • Technical Application
  • CQV documentation – drafting, reviewing and approving CQV documentation to Regulatory standards and guidelines.
  • To co-ordinate and execute Periodic Review and Requalification of company systems and facilities.
  • To co-ordinate and execute validation activity for new product introduction, or changes to secondary packaging processes.
  • Accountable for scheduling, tracking, reporting and achieving validation deadlines.
  • Input into the core aspects of Operations, Qualification and Validation SOPs
  • Actively contribute to project teams.
  • Data gathering and analysis
  • Performing data analysis and determine conclusions reached.
  • Make informed decisions / recommendations around conclusions reached from data analysis.
  • Reviewing and approval of data analysis and reporting.
  • Information transfer
  • Attends departmental and team meetings focused on CQV activities.
  • Serve as a CQV representative for internal technical group discussions.
  • Compliance
  • Understanding and applying industry specific compliance standards/regulations to all
  • Commissioning/Qualification activities with focus on ASTM E2500, Eudralex and FDA standards.
  • Developing an understanding of the importance considering impact on cGMP and compliance on decisions made.
  • Conducting and participating in Risk assessments, root cause analysis and investigations.
  • Signing off and approving protocols, reports, project change controls and deviations.
  • Proactively highlighting any issues around compliance.
  • Participates in internal and external audits and inspections where required.
  • Learning and self-development
  • Willingly accepting challenging assignments
  • Proactively keeping up to date with current thinking and best practice
  • Seeking developmental projects / opportunities and tasks to improve personal knowledge and capability.
  • Any Other duties as required by management

 

Minimum Qualifications and Experience:

  • Technical diploma or Degree in Engineering/Life Sciences or greater preferred
  • Commissioning, qualification and validation experience in GMP product manufacturing would be required (minimum of 3 years)
  • Thermal mapping experience using an independent thermal mapping system
  • Experience in HPRA/FDA environment advantageous
  • Strong technical writing and communication skills
  • Ability to close items to completion
  • Ability to pay high level of detail and QA data to very high standard
  • Problem solving skills
  • Must be goal-oriented and able to prioritize and manage risks

 

HR Business Partner - Dublin

Responsibilities:

  • Partnering with the People & Culture Lead, the incumbent will provide guidance and advice to teams on people management and creating most rewarding place to work
  • Supports execution of day-to-day HR strategy in collaboration with People & Culture Lead.
  • Assist business leaders assigned in client group to deliver their strategy by ensuring that they are structured and resourced correctly – having the right people in the right place at the right time. Build strong, effective working relationships with the senior leaders across both locations
  • Supports strategic capability initiatives in driving world class innovation and leadership and our culture values
  • Manage and participate in Employee Experience initiatives in line with HR Renewed transformation initiative at a local level with the aim of making the company the most rewarding company to work
  • Supports diagnostic intervention and problem resolution strategies to contribute HR point of view to business issues. Provides feedback to inform future programs and strategies.
  • Advocates employees needs and aims to balance those with business strategy
  • Be the key liaison with Comp and Benefits team and participate in the annual comp review across the company’s Irish facilities.
  • Support monthly payroll process for Ireland partnering with Payroll Team
  • Resolves local employee relations issues; identifies trends, opportunities and ongoing employee concerns and engagement issues and resolves underlying issues.
  • As part of the People & Culture Team for Ireland, support and drive implementation of broader, global initiatives by ensuring continuity and successful delivery of functional services- including compensation planning, performance management, succession planning, employee development, recruitment, and data governance.

 

Minimum Qualifications and Experience:

  • Bachelor’s degree in human resources, business administration, organizational development, or a related degree required
  • Substantial knowledge of HRIS systems, basic HR measurement, and process improvement techniques required
  • Project Management experience required
  • Experience in metrics reporting and analysis required
  • 10 years of experience as an HR business partner ideally within global pharmaceutical and/or manufacturing in matrix organizations
  • Experience in managing complex, multi-site and plant operations within a biopharmaceutical organization
  • Ability to coordinate and manage complex cross-functional projects given multiple competing priorities or perspectives
  • Experience of operating as part of a team of HR professionals and providing oversight and direction of work priorities and tactics for a number of specialisms including Comp & Benefits, Payroll, Budgeting and strategic resource planning
  • Ability to manage ambiguity, risk, and changing direction of projects and strategies
  • Excellent interpersonal, management skills and high professional standards for customer service and work quality; must be highly self-aware and receptive to feedback and continuous improvement
  • Excellent problem-solving, critical thinking, deductive reasoning, inductive reasoning, and analytical skills
  • Exceptional written and oral communication skills, including the ability to communicate technical or financial information to a non-technical audience
  • Experience with relevant HR systems, applications, and tools; metrics, data, and business intelligence tactics; and continuous improvement strategies
  • Superior project management skills, particularly with respect to organization, prioritization, and time management

 

Cleaning Validation Technical Specialist - Dublin

Purpose:

The Cleaning Validation Technical Specialist will support the cleaning validation activities for the cGMP manufacture of biological bulk drug substance (BDS) at the company’s facility in Dublin. The Specialist will provide cleaning validation expertise to support the facility design, start-up and routine commercial manufacturing. The Cleaning Validation Technical Specialist will be responsible for validation and verification of the cleaning used to support the technology transfer of new or existing drug substance manufacturing processes to the facility, and will be required to work in close collaboration with Process Development, Engineering, Supply Chain, Quality, Regulatory and other involved departments to ensure successful facility design, construction, start-up and qualification. The position is accountable for timely completion of cleaning validation/verification related milestones, with particular emphasis on cleaning validation for a multi-product drug substance manufacturing facility.

Responsibilities:

  • Maintain/update input to the Cleaning/Validation Master Plan to support the startup of the multi-product drug substance manufacturing facility
  • Develop and implement/update cleaning strategies for fixed and mobile parts
  • Development/update and/or optimize cleaning (CIP) cycles/methods/recipes for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers and supporting process equipment
  • Generate and execute cleaning validation protocols as required. Provide input to Standard Operating Procedures (SOPs) and Work Instructions (WI) to enable suitable cleaning sampling activities to occur
  • Work closely with colleagues within the Technical Services team, and with Quality, Commissioning, Manufacturing Operations, and Automation MCS to ensure CIP recipes, batch record instruction and standard work practices meet the needs of start-up, technology transfer, and routine manufacturing timelines in the context of cleaning verification/validation
  • Author and review process transfer/cleaning documentation, cleaning risk assessments, technical protocols and reports, cleaning verification/validation documents and supporting documentation as required
  • Prioritize cleaning verification/validation activities in line with the project schedule to ensure product submission timeline is met, and regulatory approval attained
  • Identify requirements for process, plant, or laboratory studies/trials to support cleaning verification/validation activities and to liaise closely with Operations/QC to oversee the design and execution of studies (as required)
  • Identify and implement improvements where feasible
  • Lead the execution of cleaning trials and studies on the manufacturing floor at commercial scale relating to typical BDS manufacturing areas. Temporary shift working may be required during periods of engineering batch and validation batch execution
  • Provide on the floor support for troubleshooting cleaning related issues and may lead manufacturing investigations into process deviations
  • Author and review technical documents for SOPs, master data, material specifications and/or regulatory agency submissions which related to cleaning activities
  • Serve as a subject-matter expert on cleaning validation activities during regulatory agency inspections

 

Minimum Qualifications and Experience:

  • Minimum requirement B.Sc. in Biochemistry, Biology, Chemistry or equivalent, or B.Eng. Process or Chemical Engineering
  • Minimum 5 years’ experience in Technical Services / Manufacturing / Technical Development/Quality Support in a biological bulk drug substance manufacturing organization
  • Technical and operational knowledge of Cleaning validation/verification, quality systems and regulatory requirements across multiple health authorities
  • Experience of cleaning validation is a must, and/or cleaning approaches to multi product is advantageous
  • Experience of cleaning verification/validation of downstream processing equipment (Chromatography skid, UFDF/TFF skids, Filtration skids, and process hold vessels)
  • Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing
  • Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization
  • Ability to present and successfully defend technical and scientific approaches in both written and verbal form
  • Ability to drive for results independently and adapt to rapidly changing priorities

 

QA Group Lead - Clonmel

Purpose:

Provides supervision and leadership to the team of Quality Engineers, Technicians and auditors as required, to support Manufacturing, Supplier Development, New Product Development and Quality Systems. Ensures the overall compliance and effectiveness of the quality system with established requirements and quality system regulations. Directs projects to ensure the manufacture of high quality product and to facilitate compliance with requirements. Evaluates performance of direct reports and supports career development activities. Ensures that program and project objectives are met, budgets are adhered to and metrics are captured and published.

Responsibilities:

  • Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes and coordinates the selection process with Human Resources.
  • Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
  • Monitors daily work operations and provides direction and guidance to experienced exempt employees, or skilled non-exempt staff to achieve unit or project goals.
  • Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
  • Interprets and executes policies that affect work processes and personnel within the assigned organisational unit.
  • Contributes to the development of operational policies and procedures that affect personnel within the assigned organisational unit. Monitors compliance with company policies and procedures (for example, compliance with Food and Drug Administration (FDA), British Standards Institution (BSI) and relevant employment law.
  • Monitors internal and external indicators by reviewing reports and newsletters, reading organisation literature, meeting with peers and reading departmental reports.
  • Contributes to the development and monitoring of area budgets through regular analysis of cost
  • Translates department goals into individual objectives and goals.
  • Identifies, develops and implements process and opportunities to enhance and improve overall department performance.
  • Provides manufacturing support by defining work assignments directed to address manufacturing process defects and implement process improvements utilising quality system tools.
  • May also direct work assignments for quality control auditors.
  • Directs quality personnel to support new product development by defining projects focused on new products/process development based on coordination with management, project leaders and design engineers.
  • Implements improvements to quality system and tools by directing personnel to gather data on existing quality tools, identifying weaknesses and research/select new tools based on findings and implementation of revised systems.
  • Ensure sustaining support of quality system and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.
  • Participates in validation activity.
  • Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.
  • Maintains personnel records and where appropriate develops work schedules for department personnel.
  • Responsible for disposition and investigation of any identified nonconforming materials or product identified via incoming inspection or production.
  • Responsible for management of supplier, internal and external audits, planned and unplanned, ensuring all audits are conducted as per plan audits are closed out in a timely fashion as per governing procedures.

 

Minimum Qualifications and Experience:

  • Experience/Education
  • National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline and 6+ years of related work experience or an equivalent combination of education and work experience
  • Technical/Business Knowledge
  • Monitors progress of exempt individuals, teams, supervisors or non-exempt technical individuals toward departmental goals. Monitors costs of projects and of human and material resources within a department or unit. Monitors external environment in area of technical or professional responsibility. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations
  • Cognitive Skills
  • Develops and/or identifies new work processes and the improved utilisation of human and material resources within the assigned area or related departments. Facilitates others involvement in the continuous improvement program. Investigates and solves problems that impact work processes and personnel within the assigned unit.
  • Influence/Leadership
  • Promotes the attainment of group goals by selecting , motivating and training ca able staff. Provides guidance towards achieving group objectives.
  • Planning/Organisation
  • Schedules human and material resources within a group or selection in conjunction with near term plans to ensure their availability. Carries out operations within an established budget.
  • Decision Making/Impact
  • Assignments are expresses in the form of tasks and objectives. Generally makes day-to-day decisions within established guidelines regarding work processes or schedules in order to achieve the program objectives established by senior management. Consequences of erroneous decisions would normally result in serious delays to assigned projects or operations with substantial expenditure of time, human resources and funds, without jeopardising future business activity, (Supervision Received) Works under minimal supervision. Independently determine and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
  • Supervision Provided
  • Provides direction and guidance to supervisors, experienced exempt and/or skilled non-exempt levels of employees. Evaluates performance of and assists in career development planning for subordinates. Often responsible for a local functional or process activity.

 

Process Engineer - Dublin

Purpose:

Based within the Dublin manufacturing facility, your role will be part of the Process Engineering Unit, supporting a variety of key areas on-site. You will be working across cross-functional teams with a high level of autonomy. Reporting to Process Engineering Manager.

Responsibilities:

  • Lead Technical Process Improvement Projects and Initiatives that will drive increases in bulk capacity and increases in OEE across all manufacturing operations
  • Ownership and use of process related data to drive further understanding and improvements across processes
  • Actively implement process improvements across manufacturing operations
  • Actively work with manufacturing in leading the resolution of Technical deviations, ensuring effective countermeasures are implemented to ensure Quality and Compliance standards are constantly improved
  • Provide timely process engineering solutions
  • Participate in daily walkthroughs and visual management meetings in your area
  • Support achievement of site wide goals particularly Safety, Quality, Customer Service, Financial targets
  • Ensure a responsive and committed culture is created to ensure rapid resolution of operation challenges and sound decision-making
  • Introduce new techniques and ideas

Minimum Qualifications and Experience:

  • Third level degree qualification preferably in Chemical / Process Engineering
  • Preferably certified in a Lean six sigma Qualification
  • At least 3 years’ experience in the life sciences industry working in a Technical Engineering environment
  • Knowledge of and experience in applying Six Sigma and Lean methodologies
  • Deep technical and scientific knowledge to drive process optimisation and robustness.
  • A proven track record in process development, support and improvement is required.
  • The ability to organise, plan and execute multiple tasks to tight schedules

 

IT Project Manager - Dublin

Purpose:

The IT Project Manager for the IT-Global Operations organization is responsible for the planning and execution of IT projects that includes any and all phases of the project life cycle while incorporating the system development life cycle. The Project Manager is accountable for delivering projects on time, within budget, and with high quality. IT Project Manager will work closely with the business teams and various IT functions (e.g. IT Business Partners, Solution Delivery Managers, Architects etc.) to deliver on various business transformation initiatives. This position reports to the IT Portfolio and Project management organization and focuses on the implementation of IT projects within the area of the Global Operations functions e.g. Supply Chain, Manufacturing, Facilities, EH&S.

Responsibilities:

  • Drive proper project chartering and setup.
  • Facilitate the definition of the project scope, milestones, tasks, deliverables and resource requirements.
  • Identify necessary management structures for projects and secure the management involvement required.
  • Estimate project costs and manage the budget (includes related scope control).
  • Establish a communication strategy in partnership with business and IT sponsors and effectively communicate project related information to team members, IT management, and customers throughout the project life cycle.
  • Keeps user experience in the forefront of all user-facing projects.
  • Work with technical teams and business teams when developing technologies and communication plans to provide an optimal end user experience.
  • Drive project management processes (including scope, schedule, risk, issue, resource, and budget management). Develop and maintain project plans, status reports, risk and issue logs, budget/ongoing project forecast of resources and materials and other project related artifacts.
  • Ensure that assigned projects are conducted in compliance with all department standards, policies, and guidelines.
  • Efficiently identify and resolve project issues.
  • Escalate issues that require leadership attention.
  • Responsible for managing and preparing the IT portfolio status report and dashboard for IT-Steering Committee
  • Track project metrics (for example, schedule variances and customer satisfaction) to drive effective project execution.
  • Continually identify, prioritize and mitigate project risks.
  • Perform team management, driving motivation, collaboration and performance.
  • Oversee and control any external resources contracted to the project.
  • Manage vendor relationships and drive deliverables to meet target dates.
  • Ensure business inclusion throughout the management of the project schedule, project decision making, training, etc

Minimum Qualifications and Experience:

  • Bachelor’s degree Business Management and/or Information Technology management, or equivalent
  • PMP certification, or equivalent
  • Minimum 6-8 years’ experience in Business Transformation program and/or Project management area
  • Demonstrated project management skills, with proven track record of leading broad, complex and/or strategic projects combined with the ability to execute at tactical project-level activities and tasks
  • Strong understanding and appreciation of business processes and pain points in the Operations functions, with emphasis on Supply Chain and Manufacturing
  • Experience managing the integration of IT solutions between systems e.g. SAP, Serialization, Manufacturing Execution Systems(MES), Data Lake population & reporting
  • Familiarity with best practices for partnering with SaaS and Cloud-based companies for delivery of compliant, robust systems
  • Strong understanding of SDLC, GxP Regulations and GxP Systems Validation (21 CFR Part 11, Annex 11), with focus on Good Manufacturing (GMP) and Good Distribution (GDP) practices
  • Demonstrated experience with assessing, rating, prioritising and managing IT/Business projects portfolio in biotech and/or pharmaceutical industry
  • In-depth knowledge and experience building and motivating teams, with stakeholders at all levels of the organization
  • Broad business acumen and understanding of software development processes, outsourcing and off-shoring
  • Proven experience working effectively in a matrix organization and ability to collaborate effectively across geographies
  • Integrate process, people, quality and commitment-centric approach to getting work done
  • Drive for high quality and ability to collaborate with other stakeholders to achieve high goals
  • Ability to work with different cross-functional stakeholders to establish and ensure a reliable and productive working relationship
  • Good written and oral communication skills including capacity to comfortably interface with senior leaders, including executive staff
  • Strong negotiation skills and ability to influence

 

Quality Engineer - Waterford City

Purpose:

The Quality Engineer assists in development and implementation of quality plans, programs and procedures using quality control statistics, lean manufacturing concepts and analyses. Ensures that performance and product quality conforms to established company, customer and regulatory requirements. Assists in the review, analysis and reporting on quality discrepancies related to assembly and process. May investigate problems and recommend disposition, modification and corrective action for recurring or non-recurring discrepancies. Interfaces with manufacturing, engineering, customer, vendor and subcontractor representatives to ensure requirements are met.

Responsibilities:

  • Provide technical support during the NPI process in ensuring that from a Healthcare/Medical device perspective that all FDA, QSR, & MDD standards are achieved and maintained in respect to device classifications
  • Fully competent in the application of quality engineering tools and techniques with key emphasis on validation protocols (DQ, IQ, OQ, & PQ), cGMP, PFMEA’s & support the generation of DMF’s where appropriate
  • Individual with an experienced background in sterilisation, automation, equipment/software validation
  • Individual with an experienced background in manufacturing within controlled environments
  • Individual shall support the external & internally Quality Management System auditing function (auditor trained)
  • Individual shall have exposure & involvement in supporting the CAPA system
  • Close liaison and networking with other departments, to provide and drive quality inputs and initiatives into the overall operational activities of the company
  • Support the implementation of Company Policies and GMP
  • Support all company safety and quality programs and initiatives
  • Ensure ongoing compliance with GMP in all practices, recording of events and processes
  • Ensure compliance with all learnings from all GMP training events
  • Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position

 

Minimum Qualifications and Experience:

  • Degree in Engineering / Science (Mechanical / Electronics / Chemistry) discipline
  • 3 to 5 years’ experience in a Quality Engineering role
  • Fully competent in Quality Management Standards
  • Excellent Leadership skills, ability to motivate team members within the organisation. (Energetic & enthusiastic individual)
  • Excellent organisation, communication, computer & presentation skills
  • Excellent initiative, decision making and be able to work in a core team environment
  • Solution driven with emphasis on performance and results
  • Reports to Senior Quality Engineer

 

Automation Engineer - Waterford City

Purpose:

The Automation Engineer monitors the quality and efficiency performance of assigned product lines and provides support in driving continuous improvement through process development, root cause analysis and systematic problem solving.

Responsibilities:

  • Support design, buy-off, installation and validation of automated production lines
  • Process Characterisation / Optimisation (DFMEA’s, PFMEA’s DOE’s etc.)
  • Lead systematic technical root cause investigations
  • Support production line ramp to achieve mature production targets
  • Drive continuous improvement projects
  • Manage assigned project budgets; liaise with Customers, contractors as required
  • Support technical training
  • Support all company safety and quality programs and initiatives
  • Ensure ongoing compliance with GMP in all practices, recording of events and processes
  • Ensure compliance with all learnings from all GMP training events
  • Other responsibilities may be assigned from time to time as needed, based on the evolution of the company and the requirements of the department/position

 

Minimum Qualifications and Experience:

  • Honours Degree in mechanical engineering, manufacturing engineering or similar discipline
  • 3-6 years’ experience in a manufacturing environment (high volume automated assembly experience would be an advantage as would medical device manufacturing experience)
  • Ability to work in a team environment
  • Excellent organisation, communication, computer and presentation skills
  • Systematic troubleshooting skills
  • Strong leadership of technical issue resolution
  • Lean Six Sigma skills an advantage
  • Provide innovative solutions to complex problems
  • Good data analysis skills
  • Proficient in MS Office applications, MS Project
  • CAD experience desirable
  • Travel as necessary to support equipment buy-offs and training at vendor / customer sites

 

Automation Engineer - Waterford City

Purpose:

To ensure Automation systems are operated, improved and maintained to meet Customer and compliance requirements.

Responsibilities:

  • Health, Safety and the Environment
  • Comply at all times with the Health, Safety and Environmental policy and associated procedures
  • Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do
  • Quality Compliance
  • Ensure all work carried out, is in compliance with the required standards, conforming to company, cGMP, cGLP, SOP’s and regulatory guidelines
  • Take ownership for quality compliance in all activities you are responsible for
  • Automation Systems
  • Facilitate internal resources and outside vendors in developing technical solutions for automated equipment
  • Interface with equipment vendors to ensure successful equipment delivery, integration and validation
  • Maintain PLC automation systems in a validated state in compliance with site change control
  • Understand the requirements of computer systems validation and ensure compliance is maintained
  • Act as operations support for Fill Finish and Oral Dose facilities
  • Provide technical and automation core competency support, including possible off-hours, remote and onsite coverage
  • Provide technical and automation training to Operations and Engineering personnel on an as-needed basis
  • Ensure automation systems are maintained appropriately
  • Adhere to a Life cycle management process for automation systems
  • Support process investigations and troubleshooting as required
  • Interface with Operations, IT, QS and QA groups to successfully validate software systems
  • Support delivery of projects as required, through the review and sign off of specifications, designs and commissioning protocols. Attendance at FAT’s etc
  • Support disaster recovery and back up procedures and processes to ensure business impact is minimized in the event of a failure
  • Support the integration of Fill Finish and Oral Solid Dose equipment into the company Plant Network
  • Provide automation requirements and implement solutions for new products and/or capacity expansions

 

Minimum Qualifications and Experience:

  • Engineering degree in Electrical, Electronics, Electro-mechanical or equivalent training/experience
  • Minimum of 3 year’s engineering experience within Industry, preferably Pharma
  • Experience with Siemens S7 PLCs and WinCC flexible desirable
  • Experience clean room environment a plus
  • Experience working in a cGMP/FDA/HPRA regulated environment
  • Excellent technical knowledge in all phases of GAMP.
  • Reading and interpreting PLC code.
  • Strong understanding of SCADA systems.
  • Reading and interpreting electrical drawings.
  • Understanding of Computer Systems Validation.
  • Disciplined and compliant approach.
  • Methodical/Analytical approach to problem solving.
  • Be able to work with Operations staff, Maintenance technicians and engineers in a cross-functional team setting.
  • Strong understanding of how to implement and maintain FDA 21 CFR Part 11 compliant systems.
  • Strong understanding of IP based networks, DeviceNet, Profinet, etc.
  • Strong understanding of RS485 networks especially Profibus an advantage.

 

Senior Financial Reporting Manager - Waterford City

Description:

As Senior Financial Reporting Manager, the person will be responsible for key financial processes within the organisation. The person will be responsible for a number of legal entities with the emphasis on ensuring that all statutory and tax reporting requirements are achieved, and that systems and processes are maintained and enhanced to ensure reporting requirements, both local and internationally, can be delivered in an efficient manner. In addition, the person will have responsibility within the monthly close process, ensuring timely and accurate submissions to Head office and ensuring key SOX controls are maintained. As a senior member of staff, the person will also liaise with Corporate Head office, presenting and explaining results. To this end the individual will need to gain very quickly an understanding of the business and how it operates and build key relationships within the Corporate organisation. The person appointed will need to have initiative and drive to work in a fast paced, ever changing environment. Excellent communication skills and an ability to work well within a small team are essential.

Responsibilities:

  • Full responsibility for all legal entity reporting:
  • Annual Statutory financial statements
  • Interim Statutory financial Statements
  • Annual Statutory Audit
  • Creating processes to ensure financial statements can be delivered efficiently
  • Interpreting legal documentation and accounting appropriately
  • All CSO and other statutory reporting requirements
  • SOX compliance for relevant areas
  • Tax Compliance Reporting for all legal entities:
  • Tax provisioning – current & deferred tax
  • Annual tax submissions and queries
  • Tax reporting to Corporate Tax Group
  • Tax planning with Corporate Tax Group
  • Other key responsibilities:
  • Management Fee accounting & reporting
  • FX analysis for legal entity
  • Preparation of presentations for board meetings
  • Responsibility for Government support initiatives
  • Managing grant agreements from inception to close
  • Grant applications
  • Grant claims
  • R&D Tax credits

 

Minimum Qualifications and Experience:

  • Qualified Accountant with 8+ years post qualification experience
  • Experience in accounting for complicated financial structures
  • Good working knowledge of accounting software packages required – Peoplesoft, SAP, HFM
  • Advanced Excel skills

 

Validation Engineer - Wicklow

Description:

As part of the Validation team within Quality, the Validation Engineer will be responsible for the performance and execution of Production and Cleaning Validation. The primary focus of the role will be on validation transfers of existing products to new equipment within the site.

Responsibilities:

  • Responsibility for the co-ordination of Process Validation, Cleaning Validation activity and Equipment Validation in the Production Department.
  • Preparation and execution of validation and re-validation protocols and reports, (IQ / OQ / PQ), for the validation of equipment, systems, products and projects.
  • Responsible for Investigating and resolving deviations associated with validation studies.
  • Acting as the primary point of contact for all Production related Validation matters as well as internal and external compliance audits or regulatory inspections.
  • Process Validation regulatory requests relating to the VMP.
  • Contribute to achievement of VMP and site targets.

Minimum Qualifications and Experience:

  • The successful candidate will be expected to work co-operatively and flexibly both within the Quality and Production department and with other departments across the site.
  • Excellent communication skills with a collaborative approach to work are also required.
  • Strong attention to detail, refined planning and organisation skills along with an ability to achieve objectives without close supervision in a team based environment are essential for this role.
  • A minimum of two years’ validation experience within the Pharmaceutical/Medical Devices Industry is required. Candidates should hold a Degree level qualification in a scientific or relevant discipline.

 

Senior Microbiologist - Waterford City

Description:

To be part of a microbiology department supporting state of the art Fill Finish and Oral Solid Dose facilities.

Responsibilities:

  • Laboratory
  • Introduction, validation and execution of methods.
  • Review and trend data.
  • Write, execute and approve validation documents as required.
  • Carry out investigations and address deviations.
  • Management of external testing.
  • Write, implement, review and update SOPs.
  • Support junior staff

 

  • Health, Safety and the Environment
  • Comply with all EHS policies and procedures.

 

  • Quality Compliance
  • Comply with all GMP, GLP and GDP requirements.

 

  • Production
  • Provide technical knowledge and support on sterility assurance.
  • Provide support during Media Fills.
  • Participate in risk assessments as a Subject Matter Expert (SME).
  • Provide support during production investigations.

 

  • Delegation
  • Provide support to the microbiology manager.

Minimum Qualifications and Experience:

  • BSC in microbiology or biological sciences.
  • Minimum of 5 years of experience in microbiology in a laboratory and / or aseptic production environment.
  • Demonstrated experience in providing microbiological support to a production facility.
  • Demonstrated ability to introduce, validate and optimise microbiology methods.
  • Experience working in a cross functional team environment.

 

  • Skills:
  • Introduction, validation and performance of sterility testing.
  • Operation of sterility testing isolators.
  • Microbial Limit Test validation.
  • Media Fill experience.

 

Maintenance and Reliability Manager - Waterford

Description:

The Maintenance and Reliability Engineering Manager has overall responsibility for the maintenance and reliability of all production equipment at the Waterford Site. This includes the management of the Crafts headcount and all the associated reporting and budgetary requirements

Responsibilities:

  • The Maintenance and Reliability Engineering Manager has overall responsibility for the sites Maintenance Department budget
  • Ensuring, along with the relevant Process Engineering Managers, that the sites manufacturing equipment performance meets or exceeds all required KPI
  • Management of all Safety and Quality regulatory requirement
  • Provide strategies to ensure all raft training has been identified and support the ongoing skills enhancement of Crafts and non-technical members of Maintenance teams
  • Ensure planned preventative maintenance is executed to plan and plans are in place to ensure regulatory conformance always
  • Periodic maintenance systems review, identification and execution of continuous improvement projects focused on equipment performance, application of best practice maintenance strategies to sustain these improvements long term
  • Optimization of MRO stores stock levels, collaborate with cross functional teams to ensure critical spare parts are identifies and in stock
  • Ensure all maintenance work performed onsite exceeds Health & Safety and Quality requirements

Minimum Qualifications and Experience:

  • Batchelor Degree in Engineering or another relevant technical equivalent
  • 3+ years supervisory experience, or hands on preventative / reactive maintenance, technician management within a unionised environment
  • 5+ Years’ experience of engineering / maintenance roles in high volume regulated industries with a significant technology content
  • Extensive hands on experience of high speed; highly automated manufacturing and packaging lines is a distinct advantage
  • Knowledge of medical device and/ or pharmaceutical production or alternative regulated environment (cGMP / FDA regulated)

EHS Group Lead - Clonmel

Description:

Lead EHS team to design, develop and implement site Environmental, Health & Safety programs. The Group Leader provides direction and actively supports subordinates and maximizes results through an efficient use of budgeted resources.

Responsibilities:

  • Provide overall leadership, strategy development and EHS compliance assurance with respect to:
  • Generation of an EHS culture onsite, fostering the principles of participation, compliance and continuous improvement.
  • Leadership in the development and implementation of proactive EHS management systems which facilitate compliance, are cost effective, protect the employee’s health and safety and manage our impact on the environment.
  • Leadership in the development of long-range plans to address current and future EHS issues facing the site and the divisions and development of management communications on these topics.
  • Participation in the negotiation of compliance issues with regulatory agencies as necessary and track any response to citations/violations should they occur.
  • Provision of a technical/regulatory resource in the areas of EHS and the interpretation of analytical data to determine EHS control measures, etc.
  • Project management relating to EHS investigations.
  • Manage EHS program for continuous improvement, facilitating involvement of all employees.
  • Manage site EHS training process and programs to ensure effectiveness and compliance of EHS education.
  • Support plant processes related to EHS to ensure consistency and continuous improvement.
  • Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
  • Work with the company and Corporate to maximize standardization/efficiencies and to communicate/represent the site at these levels.
  • Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
  • Monitors daily work operations and provides direction and guidance to, experienced exempt employees, or skilled non-exempt staff to achieve unit or project goals.
  • Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures
  • Contributes to the development and monitoring of area budgets through regular analysis of cost and spending. Translates department goals into individual objectives and KRAs (key result areas).
  • Identifies, develops and implements processes to improve department performance.

Minimum Qualifications and Experience:

  • Experience/Education
  • NFQ (National Framework of Qualifications) level 7 qualification in a relevant discipline.
  • 6+ years of related work experience or an equivalent combination of education and work experience.

 

  • Technical/Business Knowledge (Job Skills)
  • Monitors progress of exempt individuals, teams, supervisors or non-exempt technical individuals toward departmental goals; monitors costs of projects and of human and material resources within a department or unit; monitors external environment in area of technical or professional responsibility.
  • Will perform this job in a quality system environment.
  • Failure to adequately perform tasks can result in noncompliance with governmental regulations

 

  • Cognitive skills
  • Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned area or related departments; facilitates others involvement in the continuous improvement program; investigates and solves problems that impact work processes and personnel within the assigned unit.

 

  • Influence/Leadership
  • Promotes the attainment of group goals by selecting, motivating, and training capable staff. Provides leadership to assigned units by communicating and providing guidance towards achieving group objectives.

 

  • Planning/Organization
  • Schedules human and material resources within a group or section in conjunction with near-term plans to ensure their availability; carries out operations within an established budget.

 

  • Decision making/Impact
  • Assignments are expressed in the form of tasks and objectives; generally makes day-to-day decisions within established guidelines regarding work processes or schedules in order to achieve the program objectives established by senior management, consequences of erroneous decisions would normally result in serious delays to assigned projects or operations with substantial expenditure of time, human resources, and funds, without jeopardizing future business activity.

 

  • Supervision Received
  • Works under minimal supervision.
  • Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.

 

  • Supervision Provided
  • Provides direction and guidance to supervisors, experienced exempt and/or skilled non-exempt levels of employees; evaluates performance of and assists in career development planning for subordinates; often responsible for a local functional or process activity.

 

QC Specialist for LIMS - Meath

Description:

This role will support the Quality Control functional testing of incoming raw materials, in-process drug substance/drug product, final drug products, stability samples and environmental monitoring of the controlled manufacturing areas and utilities at the new single-use multi-product biotech facility. This facility will manufacture enzyme replacement and antibody-based therapies for a leading global biotech company focused on rare diseases. The overall responsibility for this role will be to support the Quality Control testing function, ensuring compliance with cGMP and corporate regulations. This is a critical role within the Quality organisation to help establish the Laboratories as a hub for specialised analytical testing and create value for our patients.

Responsibilities:

This role is associated with the data management systems for instrument control in the laboratories, this includes but is not limited to Labware LES (LIMS + Execution System), Lonza MoDa, Waters Empower, Mettler Lab-X. Below activities are associated with these systems;

  • Participates in defining user requirements.
  • Tests and validates the design.
  • Develops procedures and training documents.
  • Assist in the implementation at site.
  • Gather raw data for template building.
  • After vendor provided training will provide the first line of support within their laboratories.
  • Empower superuser to build and maintain custom calculation builds and system maintenance.
  • Reviewing analytical data, analytical reports and performing peer reviews.
  • Instrument qualification, maintenance and troubleshooting.
  • Protocol generation– method verification/transfer.
  • Providing training for team members.
  • Following all relevant Standard Operating Procedures.
  • Ensuring strict adherence to site policies, GMP and environmental, health and safety regulations.
  • Complies with all pertinent regulatory agency requirements.
  • Execution and on-time completion of required training activities.
  • Conducts thorough data review to ensure completeness and accuracy of records.
  • Reviews test results to ensure compliance with standards; reports any quality anomalies.
  • Participates in Laboratory Investigations as required.
  • Writes and revises control test procedures and SOPs as required.
  • May interact with outside customers or functional peer groups.
  • Promotes and exhibits company Values.
  • Executing company policies.
  • Ensuring self -inspections are performed.
  • Ensures new/revised quality system requirements are deployed to the Site

Minimum Qualifications and Experience:

  • A Level 8 Bachelor’s degree in a technical discipline (e.g. biochemistry, chemistry, engineering etc).
  • Previous GMP laboratory experience in the biotechnology and/or pharmaceutical industry.
  • Excellent communication skills (written and oral).
  • An understanding of cGMP requirements for manufacturing and/or systems and compliance.
  • Required to work on his/her own initiative in addition to working as part of a team.
  • Excellent time management & organisational skills.
  • An understanding in analytical methodology (e.g. HPLC, ELISA, SDS-Page, Glyco analytic, Bio- Assays, PCR, capillary electrophoresis, compendial assays).
  • A working understanding of GMP, ICH, USP and global compendia regulations and guidance’s, particularly as related to analytical method development and validation.
  • Previous experience with laboratory management systems such as LIMS/ MoDa/ Lab-X and / or Empower systems and interest in coding/ script.

Key Skills & Competencies:

  • Excellent trouble-shooting and problem-solving skills.
  • Ability to challenge the status quo with a continuous improvement mindset.
  • Promoting a culture where diversity and inclusion is part of the DNA.

Complexity & Problem Solving:

  • Identifying and communicating risks in area of responsibility and across the site.
  • Creating strategies and plans to manage risk within the Quality Control operation.

Internal and External Contacts:

  • For product quality, collaborates with Manufacturing, Science & Technology (MS&T) and Manufacturing Operations but is responsible for providing information to support the QMR decision.
  • For quality and compliance, collaborates with the QMR but accountable for creating a ‘right first time’ culture in the Quality group to support quality excellence.
  • For safety, the individual is accountable to drive a culture of ‘everyone owns safety’ with input from the EHS lead.
  • For continuous improvement collaborates with Business Excellence peers across the Biologics business unit in the company and through external forums to drive business excellence in Quality Assurance.

Maintenance Technician Fill Finish (Calibration / Instrumentation) - Waterford City

Description:

To ensure equipment is maintained and calibrated to meet engineering and GMP requirements. To support the Operation and Maintenance of equipment as part of the Sterile Operations Team.

Responsibilities:

  • Instrumentation, Maintenance and Operations:
  • Understand in detail how equipment operates.
  • Support the Sterile Operations Team in the reliable operation, maintenance and calibration of equipment
  • Carry out planned and reactive calibration/ maintenance as required.
  • Assist with the development of PM schedules for Fill Finish
  • Align Instrument calibrations with relevant Preventative Maintenance routines
  • Develop and comply with relevant SOP’s/WI’s.
  • Ensure spare parts requirements are available and cost effective for equipment
  • Support introduction of maintenance systems within Fill Finish
  • Support Project activities as required to ensure calibration and operational requirements are included. FAT attendance, commissioning and qualification support.
  • Procedure and Calibration assessments for new assets.
  • Problem solving techniques and associated skills are a requirement.
  • Health, Safety and the Environment:
  • Comply at all times with the Health, Safety and Environmental policy and associated procedures.
  • Continuously promote a positive safety culture by challenging yourself and others to prioritize safety in everything you do.
  • Quality Compliance:
  • Ensure all work carried out, is in compliance with the required standards, conforming to company, cGMP, SOP’s and regulatory guidelines.
  • Take ownership for quality compliance in all activities you are responsible for.

Minimum Qualifications and Experience:

  • Undergoing or have a relevant third level qualification in Instrumentation or Engineering
  • Minimum 2 years’ experience within a relevant environment (preferably within a Pharma manufacturing environment)
  • Experience in a sterile Manufacturing environment would be an advantage
  • Experience in a facility start up would be an advantage
  • Technically, highly skilled in hands on Maintenance and Calibration
  • Attention to detail
  • Knowledge of Sterile Manufacturing
  • Multi-skilled – Electrical/Mechanical/Automation
  • Can interact with audits (internal and external) providing technical information
  • Proven track record of building relations with equipment vendors
  • Report writing skills

 

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

 

Site Shift Lead - Meath

Description:

The Site Shift Lead will lead all manufacturing operations as well as support activities on their designated shift for our new state of the art single use multi-product biotech facility in County Meath, Ireland. This facility will manufacture enzyme replacement and antibody-based therapies for the leading global biotech company focused on rare diseases. Key responsibility includes leading a team of manufacturing, maintenance, automation and quality professionals who are responsible for the day to day shift operations at the site. This role will ensure that all aspects of the Meath culture including commitment to safety, right first time in everything we do and a focus on the engagement and development of employees is prioritised. This role is a critical role on the manufacturing leadership team as well as the most senior person on shift at the site.

Responsibilities:

  • SAFETY
  • Member of the site emergency response team, act as site Incident Commander in the event of an accident or incident on site.
  • Perform safety audits, walk downs and leads on safety investigations on shift – report and resolve any unsafe operations.
  • Build safety as a value within every aspect of the value stream supporting manufacturing operations that ensure sustainable EHS programmes that are engrained and deployed into each area.
  • Liaise with statutory agencies as required – and acts as primary site contact with agencies in the off hours.
  • Responsible for ensuring compliance with legal, EHS and all company policies and procedures which are applicable to the site.
  • PEOPLE
  • Ensure that all employees on shift supporting manufacturing are working as one team to support the delivery of product to patients.
  • Be responsible for the shift skills matrix to drive a learning and development organisation as well as maximising flexibility across the shift team.
  • Coach and mentor all employees on shift including all indirect employees supporting the value stream.
  • Support the creation of a high performing site organisation through implementation of a robust learning and development plan for the shift team, providing feedback to all employees on shift and the implementation of a robust communication plan to the shift including 1:1s, skip levels, development planning, and regular site updates.
  • Celebrate with use of proactive recognition tools that inspire teams and individuals.
  • Create an environment where everyone speaks up for safety and looks out for one another.
  • Be an ambassador for the company leadership behaviours of accountability, be positive, results driven and excellent manager of self and others.
  • Role model the behaviours that creates a culture of respect and dignity in line with the company guide to ethical conduct.
  • Responsible for the goal setting, ongoing performance reviews and development planning of each employee on shift.
  • OPERATIONS
  • Lead the site shift operations ensuring that all manufacturing operations are completed to schedule. This includes completion of batch record review, investigations and the completion of all scheduled activities including sampling, cleaning, preventative maintenance, calibration, changeovers, validations and projects.
  • Provide timely visibility through tier meetings and visual management on progress against value stream KPIs, delays, action plans, improvement opportunities and recognition.
  • In partnership with the manufacturing leadership team create and sustain a culture of excellence in safety, quality and continuous improvement.
  • Create an environment of right first time in everything that we do through a focus on principles of lean including simplification, standard work, visual management and a learning organisation as part of the tier meeting structure and ensure shift automation and process engineering are engaged in making changes/ improvements that support right first time improvement and error proofing.
  • Be accountable for a robust investigation process to drive to right first time.
  • Ensure objectives are aligned, integrated across the shift team, translated to all and visually managed to drive delivery.
  • Deliver on the annual business plan including all KPIs related to safety, quality, people and productivity in partnership with the site manufacturing leadership team and the value stream leadership team.
  • Represent the Meath plant internally and externally to promote the Meath plant as a great place to work and to support delivery of benchmark site performance.
  • Responsible for ensuring compliance to all requirements of current Good Manufacturing Practice.
  • Strengthening overall leadership and organizational capabilities in area of responsibility.
  • Be ready and capable of leading on discussions with auditors on plant based activities and in leading on audit walk downs.
  • Play a key role in delivering the start-up plan for the site, acting as an area SME during the handover process from commissioning through into qualification and process validation.

Minimum Qualifications and Experience:

  • A Level 8 Bachelor of Science or Engineering degree or equivalent is required.
  • Demonstrated capability in Bio-Pharmaceutical Manufacturing / Engineering or other relevant technical experience (up to 9 years)
  • Strong ability to lead a team of highly engaged employees
  • Thorough knowledge of current Good Manufacturing Practices (cGMP) and general technical and biologic operations understanding required.
  • Experience working in an automated facility would be a distinct advantage
  • Key Skills and Competencies:
  • Ability to translate the vision and goals of the company and site to the shift team.
  • Enterprise mind-set to ensure the right prioritisation for the manufacturing operations.
  • Strong planning and project management skills to support delivering the integrated manufacturing schedule.
  • Strong stakeholder management skills to manage stakeholders across the various function’s that support manufacturing.
  • Strong Talent Developer with a focus on creating a continuous learning organisation through active coaching
  • Demonstrated capability to lead a team of highly engaged employees.
  • Excellent influencing/collaboration skills and teamwork mind-set.
  • Excellent trouble shooting and problem-solving skills as well as ability to coach and mentor teams through complex problems.
  • Ability to challenge the status quo with a continuous improvement mind set.
  • Proven ability to using a wide variety of lean tools and building capability in teams you have led.
  • Change agent who will support the organisation with good change management tools and techniques.
  • Effective communicator.
  • Proven ability to grow talent.
  • Promoting a culture where diversity and inclusion is supported.
  • Ability to drive implementation of lean automated process through standard work, tier meetings, visual management and problem solving
  • Complexity and Problem Solving:
  • Identifying and communicating risks in delivery of the manufacturing schedule.
  • Creating action plans to manage risk to the operations.
  • Internal and External Contacts:
  • For Quality Organisation partner with QA Operations Support to ensure that all GMP activities that support manufacturing of product at the Meath plant are done in a consistent, compliant and a timely manner.
  • Provide support to QA on shift through a robust communication plan and ensuring they are integrated as part of the shift team.
  • For Manufacturing, Science & Technology (MS&T) collaborate to ensure the required technical support is available to the shift team during complex events including validation runs, implementation of new technology or major investigations.
  • Collaborate with Manufacturing HR Business Partner to ensure recruitment, learning and development of all employees on shift is prioritised.
  • Collaborate with other members of the manufacturing leadership team to ensure that all activities that are required to support an efficient and effective manufacturing schedule are delivered including master manufacturing recipe, change control, investigation management, projects, and master production schedule.
  • For Maintenance support the shift maintenance team to ensure preventative maintenance and calibration schedules are maintained and provides support in terms of shift priorities.
  • For Automation support the shift automation engineer in terms of priorities for actions that support closeout of action items and process improvements.
  • For Supply Chain collaborate to ensure all processes and systems supporting planning, purchasing and warehousing, distribution are developed and tracked to support PAI readiness and commercial manufacture.

QA Operations Specialist - New Product Introduction - Dublin

Responsibilities:

  • Provide quality and cGMP input and oversight focused on the transfer of new products to the site – through commercial readiness and ongoing product manufacturing and disposition for biologics facility.
  • Provide QA support for risk based verification activities in the capacity of Quality Assurance Subject Matter Expert.
  • Support the introduction of all associated new materials, including qualification of the materials and associated vendors.
  • Participate in verification quality risk assessments and provide quality oversight to ensure verification quality risk assessments are effectively maintained / controlled.
  • Review and approval of technical support documentation. (Examples include associated technical transfer documentation, process, method validation)
  • Review and approval of manufacturing batch records.
  • Review and approval of functional area documentation (SOP, Work Instructions, Criticality Assessments, technical report and protocols)
  • Provide quality support for implementation of new product on SAP.
  • 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, and batch disposition.
  • Review and approve investigations, Change Control and CAPA’s
  • Participate in investigations as required
  • Review and approve Validation protocols and reports as required.
  • Support routine manufacturing operations from a quality and compliance perspective
  • Support the vendor quality management programme.
  • Participate in regulatory inspections 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/engineering with a minimum of 3 years’ experience in cGMP Quality environment
  • Experienced QA professional with QA Operations experience
  • 3-5 years’ experience in QA positions preferably pharmaceutical and/or biotech products
  • Previous experience in technical transfer activities an advantage
  • Sound awareness and understanding of current quality and regulatory requirements
  • Familiarity in the use of enterprise systems for the management of product and associated records and quality documentation.
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels

 

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

 

Quality Assurance Manager (Lab Manager) - Clonmel

Description:

Provide management of a functional area that results in the implementation and achievement of vision, mission, and functional objectives. This position is responsible for overseeing and directing quality engineering, regulatory compliance, analytical laboratories, product release and quality control functions. Plans, develops and manages the quality organisation to assure the continuance of qualified and efficient staff to meet Corporate, Food and Drug Administration (FDA), and International Organisation for Standardisation (ISO) requirements as well as other regulatory requirements as captured in COP381.

Responsibilities:

  • Recruits, coaches and develops organisational talent.
  • Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organisational objectives.
  • Provides direction and guidance to exempt specialists and/or supervisory staff who exercise significant latitude and independence in their assignments. May supervise non-exempt employees.
  • Keeps the organisation’s vision and values at the forefront of decision making and action.
  • Demonstrates effective change leadership.
  • Builds strategic partnerships to further departmental and organisational objectives.
  • Develops and executes organisational and operational policies that affect one or more groups by utilising technical/professional knowledge and skills.
  • Makes decisions regarding work processes, operational plans and schedules in order to achieve department and site objectives.
  • Develops, monitors and appropriately adjusts the annual budget for the areas of operation.
  • Participates with manufacturing management at all levels in problems relating to quality, compliance and reliability.
  • Oversees the completion of the annual product review as requested. Establish and maintain effective structures to ensure consistent implementation of the quality system for the company as the site of legal manufacture.
  • Monitors compliance with company policies and procedures (for example; compliance with Food and Drug Administration (FDA), International Standards Organisation (ISO), Equal Employment Opportunity (EEO) regulations and standards, etcetera) and escorts inspectors/auditors for third party and unannounced inspections/audits.
  • Approves documents defining the quality system and can own documents.
  • Coordinates where required audits by external bodies to the site and supports audits as requested across the division.
  • Ensures where applicable that the internal audit schedule is executed in a timely and effective manner.
  • Drives continuous improvement / Corrective Action Preventive Action (CAPA) and validation initiatives.
  • Ensure that valid test data is used for all regulatory submissions.
  • Responsible for development and execution of a robust supplier evaluation and monitoring programme ensuring that quality materials and services are used onsite; achieved through periodic assessment and communication of supplier performance.
  • Reviews subcontractors, suppliers and service providers quality systems to ensure that purchased product fully complies with the specified requirements.

Minimum Qualifications and Experience:

  • Experience/Education
  • National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline and 9+ years of related work experience or an equivalent combination of education and work experience.
  • Set Vision & Strategy
  • Identifies and acts upon trends that can impact the business. Creates and communicates a motivating, compelling vision of the future that supports employee engagement. Develops short and long-term strategies and helps align the resources to achieve them. Translates strategies into actionable goals and plans, and then communicates them to ensure alignment of effort and purpose Cognitive skills
  • Anticipate
  • Develops scenario and contingency plans that ensure achievement of results under changing conditions and situations. Takes initiative to implement change before others. Actively gathers customer inputs in order to anticipate and fulfill their needs and requirements. Manages internal/external stakeholders to identify and address issues. Understands the situation or audience and adjusts approach to achieve desired outcomes.
  • Innovate
  • Creates an environment of experimentation and uses failure as an opportunity to learn and take alternate action. Challenges current thinking; generates new ideas and expects others to do the same. Integrates information from multiple sources to generate unique insights or new solutions that distinguish the company from the competition. Leverages diversity of people and thinking to create a competitive advantage. Collaborates across boundaries to create cross-business opportunities.
  • Build
  • Creates a sustainable infrastructure and environment that enables growth. Maintains leadership presence and emotional control in difficult situations. Provides the insight, knowledge and leadership to improve functional area and build the business. Develops, rewards and shares talent; is the type of leader others want to work with or for. Provides accurate, frequent and constructive feedback to subordinates, peers and leaders. Makes the difficult people, financial and business decisions in a timely manner.
  • Deliver Results
  • Displays continuous energy, intensity and persistence to drive the organisation forward. Delivers what is promised; holds self and others accountable for results, commitments and behaviours. Takes appropriate accountability for failure; does not blame others. Takes action in a timely manner, with urgency or caution as appropriate, but always in a planned way. Balances short and long-term priorities and maximises the opportunities for both. Addresses organisational or cultural barriers that could prevent success.
  • Supervision Received
  • Work is performed without appreciable direction. Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long-term perspective, for desired results.
  • Supervision Provided
  • Provides direction and guidance to exempt specialist and/or supervisory personnel who exercise significant latitude and independence in their assignments; evaluates performance of and assists in career development planning for subordinates; often responsible for a centralised staff or professional function of the company.

 

Molding Engineer - Clonmel

Description:

Plays a leading role in the area of the company’s 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 the company’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.

 

QA Specialist - Quality Control - Dublin

Responsibilities:

  • Responsible for quality oversight of all Quality Control related activities supporting the technical transfer, qualification and testing of all company products. Scope includes both Clinical and Commercial products, Drug Substance, Drug Product, finished product, stability programme and raw material.
  • Provide Quality oversight of Quality Control related activities at the facility.
  • Provide Quality oversight and leadership on all Quality Control site transfer related activities at the facility.
  • Provide quality oversight and leadership in the requirements of Quality Control related change controls and deviations.
  • Provide QA oversight of change controls, Laboratory Investigation Reports, deviations, Quality Control SOP’s, technical transfer documentation, validation and qualification documentation and test related documentation.
  • Provide QA and compliance support to equipment and process qualifications.
  • Participate on cross functional project teams as required.
  • Ensure quality KPIs in relation to QC activities are met.

Minimum Qualifications and Experience:

  • Academic degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering)
  • Experienced QA professional with both QA Operations and QC Analytical experience
  • 3-5 years’ experience in QA positions preferably QC operations of pharmaceutical and/or biotech products
  • Previous experience in technical transfer activities
  • Sound awareness and understanding of current quality and regulatory requirements
  • Familiarity in the use of enterprise systems for the management of product and associated records and quality documentation.
  • Strong verbal and written communication skills with well-structured communication and presentation ability to various audience levels
  • Excellent interpersonal, management skills and high professional standards for customer service and work quality; must be highly self-aware and receptive to feedback and continuous improvement
  • Excellent problem-solving, critical thinking, deductive reasoning, inductive reasoning, and analytical skills
  • Exceptional written and oral communication skills, including the ability to communicate technical or financial information to a non-technical audience
  • Experience with relevant HR systems, applications, and tools; metrics, data, and business intelligence tactics; and continuous improvement strategies
  • Superior project management skills, particularly with respect to organization, prioritization, and time management

Instrumentation Engineer - R&D Analytical - Waterford City

Description:

Provide technical support to the Laboratory departments at the facility by maintaining all laboratory instrumentation in an operational & qualified state. This role will ensure that both instrument hardware and software qualifications are completed in a timely manner. This role includes, but is not limited to activities in the following areas:

Introduction, set up and commissioning of new instrumentation.

Maintenance and calibration of existing instrumentation.

Administration and maintenance of Laboratory instrumentation software systems excluding Empower.

Responsibilities:

  • Essential duties and responsibilities include, but are not limited to, the following:
  • Develop, maintain and execute all instrumentation calibration & maintenance schedules ensuring that all stake holders are kept informed where required.
  • Perform all necessary internal instrument calibrations & maintenance, for example monthly calibration of balances, UV, FT-IR, etc.
  • Organise & manage the identification, evaluation, purchasing, installation & qualification of any new laboratory instrumentation along with all relevant documentation.
  • Organise, supervise and approve all external maintenance & calibrations carried out by external vendors on Laboratory instrumentation.
  • Develop & write all necessary SOP’s & validation protocols relating to the operation, qualification and maintenance of all laboratory instrumentation as necessary.
  • Develop a working knowledge of all instrumentation software platforms and troubleshoot them as necessary.
  • Perform/participate in instrument/method trouble shooting as required.
  • Represent the Instrumentation Laboratory function at all project meetings both internal and external as required, feeding back status updates to the group when necessary.
  • Ensure all work is carried out in compliance with the required standards, conforming to company, cGxP, SOPs and regulatory regulations and guidelines.
  • Produce and maintain accurate, GMP compliant records.
  • Identify & make recommendations for improvements within or outside the department in order to ensure the continuous improvement of the company.
  • Health and Safety
  • Ensure requirements of the company’s Safety Statement are implemented.
  • Implement safety requirements as per site documentation including SOP’s, Safety Statement and COP’s.
  • Report any instrument defects or site hazards.
  • Continuously promote a positive safety culture by leading by example.

Minimum Qualifications and Experience:

  • Requires BSc in Chemistry or related discipline; may consider another qualification with relevant experience.
  • 3 – 5 years relevant experience in a cGMP environment is required
  • Experience in any of the following would be considered advantageous:
  • Prior experience in maintenance, qualification and calibration of laboratory instrumentation.
  • Prior experience in laboratory software administration
  • Working knowledge of change controls and risk assessments
  • Prior experience in project management

Skills:

  • Troubleshooting of Analytical Instrumentation
  • Operational knowledge of laboratory instrumentation such as HPLC, UV, FT- IR, Dissolution Bath etc.
  • Operational knowledge of laboratory computerised systems e.g. Empower.
  • Computer skills and Project Management.

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

Senior Quality Engineer - Clonmel

Description:

Provide process & quality engineering support to manufacturing, helping to ensure delivery of the highest quality product to customer. Provide process & quality engineering support to product development teams, helping to ensure development of the highest quality of new products.

Responsibilities:

  • Identify the manufacturing process defects (scrap, non-conforming material and customer complaints) by dispositioning non-conforming material, identifying primary root causes and suggesting corrective and preventative actions. May be responsible for querying and bounding data to support implementation of basic product stops.
  • Develops product quality plans, documents and systems by creating product specifications, quality specifications and quality plans in conjunction with other product development team members.
  • Develops process monitoring systems by identifying critical process steps applying methods to reduce process variation in order to reduce/eliminate the cause of defects.
  • Leads process improvement efforts by identifying methods to capture quality metric data and by performing appropriate analysis methods to enhance sustaining product design and new product development.
  • Assists in creation of quality tools and training materials by understanding the limitations of existing quality tools and training materials and by helping to identify more effective tools and materials.
  • Participates in validation activity Role may very between providing input to owning activities such as protocol/report writing and managing execution of validation actives.
  • Participates in corrective and preventative action activity.

Minimum Qualifications and Experience:

  • National Framework of Qualifications (NFQ) level 7 qualification in a relevant discipline and 5+ years of related work experience.
  • Wide application of technical principals, practices and procedures. Strong understanding of business unit function and cross group dependencies knowledge and application of concepts, practices and procedures.
  • Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations.
  • Works on problems of diverse scope where analysis of situations or data requires a review of identifiable factors
  • Establishes and cultivates an extensive network of support to facilitate completion of assignments.
  • Plans, organised and prioritises non routine tasks with approval.
  • Exercises judgement 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 of resources.
  • May provide work direction and guidance to varied levels of employees.

Quality Assurance Specialist, Quality Control - Dublin

Description:

The QA Specialist for Quality Control will be responsible, with management support, for providing oversight of quality activities associated with the quality control processes at the manufacturing facility. The Specialist will contribute and guide completion of milestones associated with specific projects and support ongoing quality assurance responsibilities in support of but not limited to quality control processes at the manufacturing facility. The QA specialist will be required to support as required, packaging activities and quality systems including Change Control, Deviations and CAPA’s. Act independently to determine methods and procedures on new assignments and provide guidance to other personnel as required. Perform all responsibilities in accordance with company policies, procedures, and regulations.

Responsibilities:

  • Serve as Quality Assurance SME for quality control activities maintaining knowledge of industry standards and regulatory requirements to ensure all quality control activities are compliant.
  • Active member of the QA Operations team ensuring on-time disposition of finished product. This should be achieved through completion of the following activities:
  • Review and assess QC deviations; including performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
  • Review and assess QC Laboratory Investigations
  • Review and approve QC generated Corrective and Preventive Actions (CAPA); including tracking, follow-up, and reporting/trending and evaluating CAPAs for effectiveness.
  • Provide Quality support to QC department in method transfer or validation activities.
  • Support the work of the Quality Systems and Compliance team by the coordination and optimization of Quality Management Records relating to Deviation, Change controls and CAPA.
  • Support Global Complaints Handling Unit (GCHU) in complaint investigations.
  • Supports the business through coordination of day to day operations and change management relating to Quality e-Systems such as TrackWise
  • Generation, development and communication of Site Quality Metrics and measurements to support the on-going development of site compliance.
  • May create or revise standard operating procedures relating to various quality system elements
  • Represents Quality Assurance to guide various projects and technical meetings, as needed
  • Responsible for documenting and reporting compliance issues to management.

Minimum Qualifications and Experience:

  • Minimum of B.S. degree in Chemistry, Biology or related field
  • Minimum 3 years of experience in QA and/or QC.
  • Further technical training in the areas of problem solving, risk assessment would be an advantage
  • Thorough knowledge of cGMP/GLP/GDP and international regulatory requirements.
  • Demonstrated ability to coordinate and drive improvement in processes supporting Quality Systems or Quality Control.
  • Proven ability to identify, influence and drive process improvement.
  • English fluency written and spoken (the Company language). Efficient in SAP, firstdoc. and Trackwise® would be an advantage.

Automation Controls Engineer - Waterford City

Description:

The successful candidate would execute projects in a fast paced, multi-disciplined, cross- functional team environment

Responsibilities:

  • Develop and implement new technologies, controls and vision systems to improve cost and quality of existing strategic medical device products.
  • Facilitate internal resources and outside vendors in developing technical solutions for automated equipment. Interface with equipment vendors to ensure successful machine delivery, integration and manufacturing validation.
  • Develop specifications documents for new equipment and work closely with vendors to ensure the software related systems are correctly developed as per specifications.
  • Provide technical expertise in the validation of new technologies to ensure they meet the Safety, Quality and Operational requirements specified.
  • Develop and manage project schedules/detailed work plans in order to meet overall project goals. Communicate status of project activities on a regular basis.
  • Support product, platform and cost improvement programs by delivering qualified vision systems and acquisition software, machine controls and PLC/SCADA software. Interface with SQA, QA and Operations groups to successfully validate software systems. Author and execute software test scripts as required.
  • Identify improvement opportunities and provide business case analysis to quantify and justify automation projects.
  • Provide automation requirements and implement solutions for product lines and/or capacity expansions.
  • Provide technical and controls core competency support, including training to Operations and Engineering personnel on an as-needed basis, including possible off-hours, remote and onsite coverage rotation.
  • Travel to vendor locations for project reviews may be required.

Minimum Qualifications and Experience:

  • Degree in Electrical, Electro-Mechanical, Computer Systems or Electronic Engineering or other similar technology degree – or equivalent training/experience
  • Experience in high volume low cost manufacturing systems development desirable
  • Knowledge of software development life cycle methodologies, statistical analysis and machine vision fundamentals advantageous
  • Must be able to work with Operations staff, Manufacturing/Maintenance technicians and engineers in cross-functional team setting.
  • 5+ years’ experience with development, integration and project management of automated control systems including Vision systems, PLC’s, motion control, robotics, HMI’s and SCADA control systems software
  • Experience with equipment build, process automation, machine vision systems development and medical products advantageous.
  • Experience working in a cGMP/FDA regulated environment desirable

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.

Intermediate Molding Engineer - Clonmel

Description:

Provides support 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

  • Supports implementation and ongoing use of polymer-based injection molded components used in the manufacture of products
  • Supports molded commodities over lifecycle including product, process, quality and cost improvement initiatives, supplier and resin changes
  • Troubleshoot molding issues in conjunction with supplier and lead or 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 Modes and Effects Analysis (FMEA).
  • Identify critical dimensions and work with suppliers to ensure proper process controls are in place.
  • Participates in validation activity. Role may vary between providing input to owning activities such as protocol/report writing and managing execution of validation activities.
  • Interacts cross-functionally with internal and external customers and suppliers. Serves as a consultant for engineering or scientific interpretations and advice on significant matters.
  • Concurrent support of multiple projects.
  • Understands engineering principles, theories and concepts through to a wide range of complex and advanced problems which require novel and new innovative approaches or a breakthrough in technology.
  • Cultivates internal and external network of resources to complete tasks. May lead a project team, determining goals, objectives and managing schedules for the projects.

Qualifications:

  • Experience/Education
  • National Framework of Qualifications (NFQ) Level 7 qualification in a relevant discipline
  • 2+ years of relevant work experience or an equivalent combination of education and work experience.
  • Technical/Business Knowledge (Job Skills)
  • Working technical knowledge and application of principles, practices and procedures within the field of polymer component manufacture, in particular injection molding. General understanding of business unit functions and cross group dependencies/ relationships. Will perform this role within a quality system environment. Failure to adequately perform tasks can result in non-compliance with governmental regulations.
  • Cognitive skills
  • Works on problems of moderate scope where analysis of situations or data requires a review of identifiable factors. Exercises judgement within defined procedures and practices to determine appropriate action. Must have a broad knowledge of technical alternatives and an understanding of their impact on the systems environment.
  • Influence/Leadership
  • Cultivates a wide range of internal networks and begins to develop an external network of resources to facilitate completion of tasks. May lead a project team of moderate scope. Provides guidance to less experienced staff. Acts as a mentor to lower level individual contributors. Influence exerted at peer level and occasionally at first levels of management.
  • Planning/Organization
  • Plans, organises and prioritises own daily work routine to meet established schedule.
  • Decision making/Impact
  • Exercises authority and judgement within defined limits to determine appropriate action. Failure to achieve results or erroneous decisions or recommendations may cause delays in program schedules and may result in the allocation of additional resources.
  • Supervision Received
  • Works under general supervision. Follows established procedures. Work is reviewed with soundness of technical judgement, overall adequacy and accuracy.
  • Supervision Provided
  • May provide limited 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 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.

Instrumentation Specialist – Waterford City

Description:

To provide specialised technical support to the analytical functions to support all on-going Development, QC and Stability functions. This includes, but is not limited to, the following areas:

• Equipment Maintenance

• Calibration

• Laboratory Computerised Systems

Responsibilities:

• To perform instrument calibrations including balance monthly calibrations, HPLC, UV, FT-IR, Conductivity Meter and Dissolution baths etc.

• To organise and sign off on external PM and calibrations.

• To maintain equipment calibration and maintenance schedules.

• To perform Instrument and method trouble shooting as required.

• Attends meetings within the company to discuss changes and modifications in laboratory equipment.

• 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.

Health and Safety

  • To perform Safety Tasks – New Material Assessment Risk Assessments etc
  • Implement Safety requirements as per site documentation including SOPs, Safety Statement and COPs
  • Reports any Defects
  • If Unsure about safety requirements – ask

Minimum Qualifications and Experience:

  • Qualified to a minimum of degree level
  • At least five years’ experience working in a related technical environment is preferable but not essential
  • Troubleshooting of Analytical Equipment
  • Operation of HPLC, UV, FT-IR, Dissolution Bath etc.
  • Knowledge of laboratory computerised systems e.g. Empower
  • Computer skills and Project Management

QC Chemist – Waterford City

Description:

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

Skills/Qualifications:

  • 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

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

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.

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