Senior Bioprocess Engineer – Upstream/Downstream GMP

Caiready; Limerick; Hybrid; EUR 70,000 - 95,000; Full time

Job summary

CAI is seeking an experienced Process Engineer in Limerick to support GMP biopharma manufacturing projects. You will work across upstream fermentation and downstream purification, from design through commissioning and handover.

Key activities include process optimization, equipment commissioning, validation, and coordinating IQ/OQ/PQ protocols while adhering to cGMP standards. Travel within Ireland and internationally may be required.

Qualifications

• Degree in Chemical, Process or Mechanical Engineering (or equivalent).
• 5+ years’ experience in a biopharma or GMP-regulated environment.
• Hands-on experience in upstream and downstream bioprocess operations.
• 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 customer-focused mindset.
• Willingness to travel within Ireland and internationally when required.

Responsibilities

• Provide process engineering support for upstream bioreactor operations (Seed train, large-scale production bioreactors).
• Support process scale-up, technology transfer and NPI activities.
• Lead and support process troubleshooting, investigations and continuous improvement.
• Lead and support full lifecycle commissioning & qualification activities.
• Author, review and execute IQ/OQ/PQ and commissioning protocols.
• Participate in FAT, SAT, site acceptance and equipment installation activities.
• Support QA validation with process documentation and technical expertise.
• Specify and review cGMP process equipment, piping, and control systems.
• Review and update P&IDs and PFDs.
• Prepare engineering evaluations, risk assessments and change control docs.
• Ensure GMP, safety and regulatory compliance.
• Assist investigations into deviations and equipment issues, implementing CAPAs.

Skills

Upstream bioprocessing

Downstream purification

Process optimization

Excellent communication

Willingness to travel

Education

Bachelor's degree in Chemical/Process/Mechanical Engineering

Tools

Bioreactors

Centrifugation

Filtration

Chromatography

UF/DF

Job description

CAI is seeking an experienced Process Engineer in Limerick to support GMP biopharma manufacturing projects. You will work across upstream fermentation and downstream purification, from design through commissioning and handover.

Key activities include process optimization, equipment commissioning, validation, and coordinating IQ/OQ/PQ protocols while adhering to cGMP standards. Travel within Ireland and internationally may be required.