Senior Bioprocess C&Q Engineer – GMP & Bioreactor Systems

Cagents; Limerick; On-site; EUR 70,000 - 110,000; Full time

Job summary

CAI, a professional services company, is seeking a Senior Commissioning & Qualification (C&Q) Engineer in Limerick to support a high-profile biopharma project.

You will lead C&Q activities for upstream and downstream equipment, including bioreactors, filtration, and concentration systems, ensuring GMP compliance and cross-functional collaboration. This is site-based with a 40-hour week and travel within Ireland and internationally may be required.

Qualifications

• Degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline.
• 5+ years’ experience in Commissioning & Qualification / CQV / Validation.
• Strong GMP knowledge and familiarity with FDA/EMA regulations.
• Hands-on upstream and downstream bioprocess knowledge including bioreactors, filtration, and concentration systems.
• Excellent documentation and stakeholder engagement skills.

Responsibilities

• Lead and execute full lifecycle Commissioning & Qualification (C&Q) activities for upstream & downstream process equipment.
• Commission and qualify bioreactor systems from development to large commercial-scale reactors.
• Support downstream processing including Filtration systems (TFF / UF / DF), Concentration and purification systems.
• Review and execute C&Q documentation (IQ, OQ, PQ protocols, Traceability matrices and final reports).
• Ensure all activities comply with GMP regulatory requirements.
• Collaborate cross-functionally with Engineering, Automation, Validation, QA, Manufacturing, and Project teams.
• Support deviations, change controls, CAPAs, and regulatory inspections.

Skills

CQV experience

GMP knowledge

Bioprocess knowledge

Bioreactors handling

Documentation & communication

Education

Degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline

Job description

CAI, a professional services company, is seeking a Senior Commissioning & Qualification (C&Q) Engineer in Limerick to support a high-profile biopharma project.

You will lead C&Q activities for upstream and downstream equipment, including bioreactors, filtration, and concentration systems, ensuring GMP compliance and cross-functional collaboration. This is site-based with a 40-hour week and travel within Ireland and internationally may be required.