Senior C&Q Engineer

CAI • Limerick, PA

6h • Onsite

About The Position

We are seeking Senior Commissioning & Qualification (C&Q) Engineers with strong hands-on experience across both upstream and downstream bioprocessing to support a large-scale, high-profile biopharma project . The core focus of this project is the commissioning and qualification of bioreactor systems , ranging from small-scale units up to large commercial-scale systems . The role also includes upstream anddownstream process equipment , supporting material flow through filtration and concentration systems , resulting in small-volume, high-value product that is shipped to Western Europe for final drug product manufacturing . This is a high-impact, technically challenging role , ideal for senior-level C&Q professionals seeking involvement in cutting-edge biomanufacturing projects .

Requirements

• Degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related discipline
• 5+ years’ experience in Commissioning & Qualification / CQV / Validation
• Strong working knowledge of GMP requirements, FDA and EMA regulations
• Strong hands-on upstream and downstream bioprocess knowledge
• Extensive experience working with Bioreactors, Filtration and concentration systems
• Excellent documentation, communication, and stakeholder engagement skills
• This is a site-based role. Must be able to commit to a minimum 40-hour work week, with flexibility based on project needs.
• Willingness to travel within Ireland and internationally , if required.
• Eligible to work full-time in Ireland.

Responsibilities

• Lead and execute full lifecycle Commissioning & Qualification (C&Q) activities for upstream and 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 .

What This Job Offers

• Job Type: Full-time
• Career Level: Senior