Senior CQV Shakedown Engineer – Biopharma Systems

CAI; Limerick; On-site; EUR 70,000 - 90,000; Full time

Job summary

CAI is seeking a Senior C&Q Engineer in Limerick to support commissioning activities on a high-profile biopharma project. This role will require execution, optimisation, and stabilisation of bioprocessing systems. You will act as the Commissioning SME, leading system setup and performance tuning, supported by a strong background in GMP, FDA/EMA regulations, and substantial bioprocess experience. Must be flexible for travel and commit to a minimum 40-hour work week.

Qualifications

• 10+ years’ experience in Commissioning & Qualification / CQV / Validation.
• Strong working knowledge of FDA and EMA regulations.
• Extensive experience working with bioprocessing systems.

Responsibilities

• Lead commissioning activities for equipment packages.
• Conduct system inspections and ensure mechanical integrity.
• Troubleshoot complex technical issues during commissioning.

Skills

GMP requirements knowledge

Hands-on upstream and downstream bioprocess knowledge

Documentation and communication skills

Stakeholder engagement skills

Education

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

Tools

Bioreactors

Filtration systems

CIP/SIP systems

Job description

CAI is seeking a Senior C&Q Engineer in Limerick to support commissioning activities on a high-profile biopharma project. This role will require execution, optimisation, and stabilisation of bioprocessing systems. You will act as the Commissioning SME, leading system setup and performance tuning, supported by a strong background in GMP, FDA/EMA regulations, and substantial bioprocess experience. Must be flexible for travel and commit to a minimum 40-hour work week.