Senior Biopharma C&Q Engineer - Lead Up/Downstream Systems

Caiready; Limerick; Hybrid; EUR 110,000 - 140,000; Full time

Job summary

CAI in Limerick is seeking an experienced Lead Commissioning & Qualification (C&Q) Engineer to lead C&Q activities across bioprocess systems on a large biopharma project. This senior role requires coordination with on-site leaders and cross-functional teams.

Responsibilities include oversight of IQ/OQ/PQ, risk assessments, and robust documentation, with a focus on GMP compliance and regulatory readiness. Travel within Ireland and internationally may be required.

Qualifications

• Degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline.
• 10+ years’ experience in Commissioning & Qualification / CQV / Validation.
• Strong working knowledge of GMP requirements, FDA and EMA regulations.
• Extensive experience with upstream/downstream bioprocess knowledge and bioreactors.

Responsibilities

• Lead and oversee the full lifecycle of Commissioning & Qualification (C&Q) activities across upstream and downstream process systems, collaborating with on-site C&Q Lead.
• Act as the primary escalation point for technical issues, driving troubleshooting, resolution, and risk mitigation across all C&Q workstreams.
• Develop and manage the overall C&Q documentation, including Commissioning Plans, IQ/OQ/PQ protocols, traceability matrices, and summary reports.
• Support system handover to Operations, ensuring all punch-list items are resolved and systems meet operational and regulatory requirements.

Skills

Leadership

Communication

Documentation

Stakeholder engagement

Education

Engineering degree

Tools

Emerson DeltaV

Job description

CAI in Limerick is seeking an experienced Lead Commissioning & Qualification (C&Q) Engineer to lead C&Q activities across bioprocess systems on a large biopharma project. This senior role requires coordination with on-site leaders and cross-functional teams.

Responsibilities include oversight of IQ/OQ/PQ, risk assessments, and robust documentation, with a focus on GMP compliance and regulatory readiness. Travel within Ireland and internationally may be required.