Senior Process Engineer

Cagents; Limerick; On-site; EUR 65,000 - 90,000; Full time

Job summary

Cagents in Limerick is seeking an experienced Process Engineer with strong upstream and downstream bioprocessing expertise to support GMP manufacturing projects. The role covers design through commissioning, qualification, and handover, with focus on bioreactor systems, purification steps, and process optimization.

Responsibilities include supporting upstream bioreactor operations, downstream processing, technology transfer, NPI, and QA documentation.

Qualifications

• Degree in Chemical, Process, or Mechanical Engineering.
• 5+ years in biopharmaceutical or GMP environment.
• Hands-on upstream and downstream bioprocess experience.
• Experience with bioreactors, centrifugation, filtration, chromatography, and UF/DF.
• Knowledge of CIP systems and clean utility design.
• Experience supporting GMP pharmaceutical or biotech manufacturing projects.
• Excellent communication skills.
• Willingness to travel within Ireland and internationally.

Responsibilities

• Provide process engineering support for upstream bioreactor operations (Seed train operations, Large-scale production bioreactors).
• Support downstream processing (centrifugation, filtration, chromatography, UF/DF).
• Support process scale-up, technology transfer, and New Product Introduction (NPI) activities.
• Lead and support process troubleshooting, investigations, and continuous improvement initiatives.
• Lead and support full lifecycle commissioning & qualification (C&Q) activities.
• Author, review, and execute IQ/OQ/PQ and commissioning protocols.
• Participate in FAT, SAT, site acceptance, and equipment installation activities.
• Support QA Validation teams with process documentation and technical expertise.
• Specify and review P&IDs and Process Flow Diagrams (PFDs).
• Prepare engineering evaluations, technical risk assessments, and change control documentation.
• Ensure full compliance with GMP, safety, and regulatory standards.
• Support investigations into process deviations, equipment issues, and safety events, implementing CAPAs.

Skills

Process engineering

Biopharma GMP

Upstream & downstream

Bioreactors

CIP systems

Communication

Travel readiness

Education

Degree in Chemical/Process/Mechanical Engineering

Tools

Bioreactors

Centrifugation

Filtration

Chromatography

UF/DF

Job description

Process Engineer – Limerick (Staff or Contract)

Job Summary: We are currently seeking an experienced Process Engineer with strong upstream and downstream bioprocessing experience to support complex GMP manufacturing projects within a leading biopharmaceutical environment. This role is heavily focused on bioreactor systems, upstream and downstream purification processes, supporting activities from process design through commissioning, qualification, and operational handover. The successful candidate will play a key role in process optimization, equipment commissioning, and validation, working across both upstream fermentation and downstream purification operations, ultimately supporting drug substance production for global supply.

Key Responsibilities

• Provide process engineering support for upstream bioreactor operations (including: Seed train operations, Large-scale production bioreactors).
• Support downstream processing (including: Centrifugation, Filtration systems, Chromatography, Ultrafiltration / Diafiltration (UF/DF)).
• Support process scale-up, technology transfer, and New Product Introduction (NPI) activities.
• Lead and support process troubleshooting, investigations, and continuous improvement initiatives.
• Lead and support full lifecycle commissioning & qualification (C&Q) activities.
• Author, review, and execute IQ/OQ/PQ and commissioning protocols.
• Participate in FAT, SAT, site acceptance, and equipment installation activities.
• Support QA Validation teams by providing process documentation and technical expertise.
• Specify and review cGMP process equipment, piping, and control systems.
• Review and update P&IDs and Process Flow Diagrams (PFDs).
• Prepare engineering evaluations, technical risk assessments, and change control documentation.
• Ensure full compliance with GMP, safety, and regulatory standards.
• Support investigations into process deviations, equipment issues, and safety events, implementing CAPAs.

Qualifications

• Degree-qualified in Chemical, Process, or Mechanical Engineering (or equivalent experience).
• 5+ years’ experience in a biopharmaceutical or GMP-regulated environment.
• Strong hands-on experience in both upstream and downstream bioprocess operations.
• Proven experience with Bioreactors, centrifugation, filtration, chromatography, and UF/DF.
• Solid understanding of CIP systems and clean utility design.
• Experience supporting GMP pharmaceutical or biotech manufacturing projects.
• Excellent communication skills with a strong customer-focused mindset.
• Willingness to travel within Ireland and internationally when required.

Other Requirements

• This is a site-based role. Must be able to commit to a minimum 40-hour work week, with flexibility based on project needs.
• Willingness to travel within Ireland and internationally, if required.
• Eligible to work full-time in Ireland.