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Location: Dublin

About the company:

Innopharma Technical Services, part of Innopharma Group, specialises in the training and provision of highly skilled, project ready, Contract Engineers & Scientists to the (Bio) Pharmaceutical and MedTech Manufacturing Sector and provides recruitment support to our clients’ in these industries.

We are now seeking a Quality Technician – QC Analyst to provide support to our client site based in Dublin.

Role Type: Onsite role, no shifts.

About the position:

The Quality Technician – QC Analyst will be part of QC Department in a state-of-the-art, single-use, multi-product biotech facility in Dublin. The QC Analyst will support analytical testing across in-process, drug substance, drug product, and stability samples. The role focuses on Biochemistry and Cell Biology methods, ensuring full compliance with cGMP and corporate standards.

Key Responsibilities:

• Perform analytical testing (e.g., ELISA, PCR, bioassays, cell culture, compendial methods) in compliance with GMP
• Document, review, and approve laboratory data accurately
• Support laboratory operations including audit readiness, equipment qualification, calibration, and maintenance
• Participate in method transfer, validation, and verification activities
• Ensure adherence to SOPs, GLP/cGMP, and regulatory requirements
• Identify, investigate, and resolve deviations, non-conformances, and anomalies
• Contribute to continuous improvement initiatives using Lean principles and data-driven decision-making
• Maintain high standards of safety, including risk assessments and proactive hazard identification
• Collaborate across teams to solve problems and improve efficiency
• Participate in inspections, GEMBAs, tier meetings, and site walkdowns
• Support site strategy, value stream improvements, and project implementation
• Mentor/train team members and support knowledge sharing
• Maintain laboratory cleanliness, organisation, and material/sample control

Preferred Experience:

• Bachelor’s degree in Science, Quality, or related technical discipline
• Minimum of 3 yrs GMP laboratory experience in biotech/pharmaceutical industry
• Hands-on experience with analytical techniques (e.g., ELISA, PCR, bioassays) preferred
• Strong understanding of cGMP/GLP and regulatory compliance
• Excellent analytical, troubleshooting, and problem-solving skills
• Continuous improvement mindset with Lean knowledge (Lean Six Sigma desirable)
• High attention to detail and commitment to quality, safety (EHS Stds) and compliance
• Ability to manage multiple priorities and escalate issues appropriately
• Strong organisational and time management abilities
• Effective communication and collaboration skills
• Ability to work independently and within cross-functional teams
• Proactive, adaptable, and self-motivated.

Note:

• All applicants must be eligible to work in Ireland without Visa sponsorship.

Apply Now

If you’re passionate about manufacturing excellence and eager to grow in a fast-paced, regulated environment, we want to hear from you. Please send your CV to: [email protected]

Innopharma Technical Services, part of Innopharma Group, is seeking a Senior Manufacturing Bioprocess Associate to provide support to our multinational Biopharmaceutical client site based in Dublin.

About the position:

The Senior Manufacturing Bioprocess Associate (BPA) is responsible for executing and supporting all procedures associated with the manufacture of Drug Substance within a single-use biopharmaceutical manufacturing facility. This role ensures operations are carried out to the highest standards of Safety, Quality, and Compliance in a regulated GMP environment.

This is a site-based shift role within a high-performing manufacturing team, focused on delivering safe, compliant, and reliable production of sterile biologics. The role involves operating and monitoring process equipment, maintaining cleanroom and materials standards, supporting troubleshooting and maintenance activities, and contributing to investigations and continuous improvement initiatives.

The ideal candidate demonstrates a growth mindset, a “right-first-time” approach, strong ownership, and the ability to thrive in a fast-paced GMP manufacturing environment.

Key Responsibilities:

• Execute and support manufacturing and production operations, including assembly, processing, equipment operation, and packaging activities in accordance with GMP requirements.
• Develop and execute production schedules based on product demand, equipment availability, material readiness, staffing levels, and operational capacity.
• Perform all required preparatory, in-process, and finishing activities in line with regulatory requirements and site procedures.
• Operate within classified cleanroom environments, ensuring adherence to validated and qualified manufacturing processes.
• Support end-to-end production operations across both Fed-Batch and Continuous Manufacturing platforms.
• Operate and monitor equipment in accordance with Electronic Batch Records (EBR), sampling plans, and Standard Operating Procedures (SOPs).
• Support the authoring and revision of EBRs, SOPs, work instructions, and sampling plans as required.
• Participate in troubleshooting activities and contribute to root cause investigations and corrective actions.
• Maintain strict adherence to site safety, quality, and compliance standards at all times.
• Work collaboratively as part of a cross-functional process team, demonstrating flexibility and strong teamwork.
• Support manufacturing operations, including occasional weekend or out-of-hours work as required.
• Contribute to continuous improvement initiatives to enhance process efficiency, reliability, and compliance.
• Operate with minimal supervision, demonstrating strong technical competence and independent decision-making.

Preferred Experience:

• Level 7 qualification in a Science, Engineering, or related discipline is desirable.
• Level 6 qualification with a minimum of 3+ years’ experience in a GMP manufacturing environment may be considered equivalent.
• Strong troubleshooting and practical problem-solving skills within a regulated manufacturing setting.
• Proven ability to work independently and collaboratively in a cross-functional team environment.
• Working knowledge of contamination control principles and batch release requirements.
• Understanding of upstream and downstream unit operations in monoclonal antibody (mAb) manufacturing.
• Familiarity with both batch and continuous bioprocessing systems.
• Experience with automation systems such as Emerson DeltaV and PAS-X.
• Experience working in single-use technology environments, preferably end-to-end single-use facilities.
• Exposure to commissioning and qualification (C&Q) activities is advantageous.
• Flexible approach to shift work and site-based operational requirements.

Note:

• Due to the nature of the business, additional duties may be assigned from time to time.
• All applicants must be eligible to work in Ireland.
• All applicants must be willing to work in shifts.

Apply Now

If you’re passionate about manufacturing excellence and eager to grow in a fast-paced, regulated environment, we want to hear from you. Please send your CV to: [email protected]

About the Company:

Innopharma Technical Services, part of Innopharma Group, specialises in the training and recruitment of highly skilled, project-ready, Engineers & Scientists to the (Bio) Pharmaceutical and MedTech Manufacturing Sector.

We are supporting a global life sciences client in the province of Leinster with the appointment of a Quality Assurance Specialist.

About the position:

The Quality Assurance Specialist will support the activities related to QA within the company. This position will report to Quality Manager.

The position is shift based & onsite.

Key Responsibilities:

The Quality Assurance Specialist is required to:

• Technical knowledge of sterile manufacturing processes.
• Perform timely reviews of batch documentation / investigations / reports highlighting and assist in the resolution of concerns commensurate with the risk.
• Respond quickly to unplanned events, technical issues.
• Operational experience of quality systems in a dynamic manufacturing environment eg SAP, Trackwise, MES.
• Full understanding of relevant quality and compliance regulations knowledge of requirements for cGMP, US and EU regulatory requirements.
• Conduct, report and display of Quality right first time, audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance.
• Support the spot check/walk-through process of the production lines.
• Involved in customer complaint investigation if required.
• Work well cross functionally and be an active team member.
• Provide Quality support to IPT production teams to ensure cGMP standards are maintained.
• Understanding of sterile manufacturing operations is preferred.
• Ability to learn and utilize computerized systems for daily performance of tasks.
• Ability to prioritize, manage multiple tasks, and meet deadlines.
• Perform timely reviews on batch documentation (EBR’s)/ line clearances/ assist in the resolution of concerns commensurate with the risk. Liaise with other Department representatives to promote improvements in GMP and Quality standards.
• Comply with our current Manufacturing Division, Quality and EHS Management System requirements, as relevant to commercial operations.

Preferred Experience:

• Minimum Level 8 Bachelor’s Degree or higher preferred in a Science discipline.
• 1-2 years’ experience in a Quality Role at pharmaceutical manufacturing
  facility preferably aseptic manufacturing.
• Experience in SAP, MES, Trackwise desirable.
• Working knowledge of regulatory/code requirements to Irish, European and International
  Codes, Standards and Practices.
• Knowledge of cGMP and GDP essential Report, standards, policy writing skills required.
• Previous experience in a quality function or in an aseptic environment is beneficial.

Note:

• It is a shift-based role – 4 cycle, 12 hours per shift with a shift allowance of 33%
• Due to the nature of the business, additional duties may be required/assigned from time to time.
• All applicants must be eligible to work in Ireland.

Apply Now

If you’re passionate about manufacturing excellence and eager to grow in a fast-paced, regulated environment, we want to hear from you. Please send your CV to: [email protected]

About the Company:

Innopharma Technical Services, part of Innopharma Group, specialises in the training and recruitment of highly skilled, project-ready, Engineers & Scientists to the (Bio) Pharmaceutical and MedTech Manufacturing Sector.

We are supporting a global life sciences client in province of Leinster with the appointment of a Validation Engineer to take ownership of validation for Equipment and Cleaning activities.

Location: Leinster

About the position:

A Validation Engineer will support several aspects of Validation in the following areas:

• Sterilisation – Autoclaves, SIP of vessels
• Cleaning – Parts Washer and CIP of vessels.
• Isolator (Filling, Sterility & Material Transfer isolators) – HVAC, VHP, E-Beam and Depyrogenation
• systems.
• Controlled Temperature Units (CTU) – Temperature/Humidity Mapping.

Key Responsibilities:

• Design, author, review, approve, and execute qualification/validation documentation, cycle development studies, and change controls in line with the standard approval process.
• Resolve technical issues encountered during study execution and engage with Production,
• Maintenance, and Quality representatives during Cycle Development and Performance
• Qualification activities.
• Provide technical input into quality notifications by authoring, reviewing, and approving investigations, including performing root cause analysis of system failures and substandard performance using standard tools and methods.
• Support continuous improvement through Lean Six Sigma methodologies and serve as the validation representative for cross-functional projects and global technical forums.
• Ensure compliance with Global Policies, Procedures, Guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP) in all activities, considering GMP impact in decision-making.
• Maintain compliance through documentation completion, risk assessments, closure of corrective actions, participation in audits and inspections, and proactive identification of compliance issues.
• Support regulatory audits and submissions, collaborate to promote a safe and compliant culture in Carlow, and perform other duties as assigned.

Preferred Experience:

• Minimum Level 8 degree in relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
• Proven track record of delivering excellence with demonstrated experience leading technical projects and supporting continuous professional development.
• Strong knowledge of equipment and process validation within GMP environments, including CTU equipment qualification, equipment validation lifecycle, periodic validation, and exception/deviation management and change control.
• Expertise in thermal/temperature mapping, thermal mapping equipment, and the ability to analyse and interpret complex data linked to equipment performance and out-of-specification findings.
• Knowledge of sterile fill-finish processes and equipment, including autoclave/SIP sterilisation validation, dry heat sterilisation, isolator qualification, filter validation, container closure validation, cleaning validation, and vial and syringe processing technologies.
• Familiarity with process monitoring systems, automation systems (DeltaV), operational intelligence and data systems (PI System), and proficiency in Microsoft Office and related computer applications.
• Understanding of Irish, European, and international regulatory/code requirements, with strong report writing, standards and policy development skills.
• Excellent communication, presentation, and interpersonal skills with the ability to interface effectively with colleagues at all levels and external customers in a team-oriented environment.
• Project management skills/qualification considered advantageous.

Note:

• Due to the nature of the business, additional duties may be required/assigned from time to time.
• All applicants must be eligible to work in Ireland.

Apply Now

If you’re passionate about manufacturing excellence and eager to grow in a fast-paced, regulated environment, we want to hear from you.

About the Company:

Innopharma Technical Services, part of Innopharma Group, specializes in the training and provision of highly skilled, project ready, Contract Engineers & Scientists to the (Bio) Pharmaceutical and MedTech Manufacturing Sector.

We are now seeking a Manufacturing Projects Scientist/ Engineer to support our client based in Dublin.

About the Position:

This role will support the New Products introduction activities and is a key contributor and part of the site network team for sustainable biologics manufacturing capacity.

This position will report into the Associate Director for new product introduction within the Manufacturing group.

Key Responsibilities:

• Contribute to cross-functional teams (Manufacturing, Engineering, QA, QC, Regulatory, Supply Chain, etc.) to support NPI activities, process improvements, technology transfer, and new product start-ups.
• Support NPI risk assessments, changeover protocols, process impact assessments, and the introduction/qualification of new raw materials and consumables to ensure manufacturing readiness.
• Prepare and approve GMP manufacturing documentation (procedures, eBRs, batch records) for development, engineering, and PPQ batches, and provide technical training and knowledge transfer to Operations and BPAs.
• Identify, lead, and support process improvement initiatives, OE activities, error-reduction efforts, and “Right First-Time” cultural implementation.
• Own and drive change controls, CAPAs, investigations, audits (internal and external), and product disposition support.
• Provide SME input to optimize new manufacturing processes and support the implementation of new technology solutions, including Single-Use systems.
• Support sustaining operations as needed to ensure product supply and coordinate operational activities such as purchasing and cross-team communication.
• Represent Manufacturing in meetings to ensure end-user requirements are captured and collaborate with sustaining teams to assess current issues and the impact of new products.
• Build strong collaborative relationships with Quality, Engineering, Technical Services, Supply Chain, Regulatory Affairs, HR, and Finance.

Preferred Experience:

• Bachelor’s/Master’s degree in Science, Engineering, or related field preferred
• Strong knowledge of GMP biologics manufacturing equipment and process automation.
• Strong working knowledge of DeltaV, MES Syncade, SAP, and excellent presentation skills.
• Demonstrated problem-solving and project management capability, including experience with lean manufacturing and closing complex technical investigations.
• Strong organization, planning, and adaptability to changing business needs.
• Proven communication, collaboration, leadership skills.

Note:

• Applicants must be residing in Ireland.
• All Applicants must be eligible to work in Ireland with Valid work Visa.

Apply Now

If you’re passionate about manufacturing excellence and eager to grow in a fast-paced, regulated environment, we want to hear from you. Please send your CV to: [email protected]

About the Company:

We at Innopharma are seeking a highly motivated QC Microbiology Specialist to join our multinational client’s site based in Dublin and support their growing Quality Control team. As a QC Microbiology Specialist, you will support environmental monitoring, aseptic process qualification, and microbiological testing activities within a GMP-regulated manufacturing environment.

This is an excellent opportunity for a proactive microbiology professional to advance their career while contributing to the delivery of high-quality, safe, and compliant products.
Candidates must be willing to work shifts.

Key Responsibilities:

Environmental & Utility Monitoring

• Performing cleanroom, Biological Safety Cabinet (BSC), and isolator batch-related monitoring.
• Conducting utility sampling of water systems and Compressed Air/Gas.

Microbiological & Analytical Testing

• Carrying out in-process testing, including HPLC and UV Spectrophotometry.
• Issuing, receiving, and testing Biological Indicators (BIs).
• Reading, reporting, and documenting results for environmental monitoring, BIs, and aseptic qualification samples.
• Conducting microbial identification for isolates recovered during routine testing.

Aseptic Processing Support

• Supporting media fill (APS) activities, including reconciliation and inspection of media fill units.
• Ensuring compliance with SOPs, registered specifications, and GMP documentation standards.

Documentation

• Completing laboratory documentation accurately and in a timely manner.
• Assisting in the authoring and review of SOPs and technical documents.
• Collaborating with cross-functional teams to meet qualification and production timelines.
• Investigating alert/action limit excursions per site procedures.

Laboratory Standards

• Maintaining a high level of housekeeping, safety, and aseptic discipline in the laboratory.
• Supporting Lean lab and 6S initiatives to drive continuous improvement.
• Performing additional tasks as assigned by the Microbiology Manager.

Preferred Experience:

• Minimum Level 8 degree in Microbiology or a related discipline.
• At least 2 years’ experience in a pharmaceutical, biotechnology, healthcare, or regulated laboratory environment.
• Utility sampling of Compressed Air/Gas is essential.
• Hands-on cleanroom and aseptic technique experience; isolator experience is a plus.
• Isolator batch-related monitoring is essential.
• Issuance, receipt, and testing of Biological Indicators is essential.
• Reconciliation and inspection of media fill units, including participation in APS/media fills, is essential.
• Desirable (not essential): experience with HPLC, UV Spectrophotometry, MODA, Empower, CIMS, LIMS, LES, or Veeva Vault.
• Strong written and verbal communication skills.
• A collaborative mindset and the ability to work effectively within a team.

Note:

• All Applicants must be eligible to work in Ireland without VISA sponsorship.
• All applicants must be willing to work in shifts.

Apply Now

If you’re passionate about manufacturing excellence and eager to grow in a fast-paced, regulated environment, we want to hear from you. Please send your CV to: [email protected]