Senior Bioprocess Engineer – Upstream & Downstream

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

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.