Lead C&Q Engineer: Biopharma Commissioning Leader

Cagents; Limerick; On-site; EUR 80,000 - 100,000; Full time

Job summary

Cagents in Limerick is looking for an experienced Lead C&Q Engineer to oversee commissioning and qualification activities for a high-profile biopharma project. This role requires strong leadership and technical expertise in upstream and downstream bioprocessing systems.

The successful candidate will ensure compliance with GEP and GMP standards and provide mentorship to junior engineers. Candidates must have a minimum of 10 years' experience in CQV and a degree in a relevant discipline. The position is site-based with a 40-hour work week.

Qualifications

• 10+ years’ experience in Commissioning & Qualification / CQV / Validation.
• Strong working knowledge of GMP requirements, FDA and EMA regulations.
• Extensive experience working with bioreactors, filtration, and concentration systems.

Responsibilities

• Lead C&Q activities across upstream and downstream process systems.
• Act as the primary escalation point for technical issues.
• Conduct system walkdowns and readiness reviews for IQ commencement.

Skills

GMP requirements

FDA and EMA regulations

Upstream and downstream bioprocess knowledge

Documentation skills

Communication skills

Stakeholder engagement

Education

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

Tools

Bioreactors

Filtration systems

Concentration systems

Job description

Cagents in Limerick is looking for an experienced Lead C&Q Engineer to oversee commissioning and qualification activities for a high-profile biopharma project. This role requires strong leadership and technical expertise in upstream and downstream bioprocessing systems.

The successful candidate will ensure compliance with GEP and GMP standards and provide mentorship to junior engineers. Candidates must have a minimum of 10 years' experience in CQV and a degree in a relevant discipline. The position is site-based with a 40-hour work week.