Senior C&Q Engineer – Bioprocess & Bioreactor Systems

Caiready; Limerick; Hybrid; EUR 90,000 - 120,000; Full time

Job summary

CAI is seeking a Senior Commissioning & Qualification (C&Q) Engineer in Limerick for a large biopharma project. You will lead C&Q activities for upstream and downstream equipment, from development-scale to commercial reactors, ensuring GMP compliance and thorough documentation.

Based in Ireland, this site-based role requires 40 hours per week with some travel. You will collaborate with Engineering, Validation, QA and Manufacturing to deliver readiness for Western Europe drug product

Qualifications

• Degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline.
• 5+ years’ experience in Commissioning & Qualification / CQV / Validation.
• Strong GMP knowledge and regulatory experience (FDA/EMA).
• Experience with bioreactors, filtration, and concentration systems.
• Excellent documentation and stakeholder engagement.

Responsibilities

• Lead and execute full lifecycle Commissioning & Qualification (C&Q) activities for upstream & downstream process equipment.
• Commission and qualify bioreactor systems, ranging from small development scale to large commercial-scale reactors.
• Support downstream processing (including: Filtration systems (TFF / UF / DF), Concentration and purification systems).
• Review and execute C&Q documentation (including: Commissioning Plans, System Impact Assessments (SIA), Risk Assessments (FMEA), IQ, OQ, and 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

Commissioning & Qualification

GMP knowledge

Upstream bioprocess

Downstream bioprocess

Documentation

Education

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

Job description

CAI is seeking a Senior Commissioning & Qualification (C&Q) Engineer in Limerick for a large biopharma project. You will lead C&Q activities for upstream and downstream equipment, from development-scale to commercial reactors, ensuring GMP compliance and thorough documentation.

Based in Ireland, this site-based role requires 40 hours per week with some travel. You will collaborate with Engineering, Validation, QA and Manufacturing to deliver readiness for Western Europe drug product