Senior C&Q Engineer

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Job Title: C&Q Engineer

Location: Limerick Contract Type: Staff or Contract

Job Summary

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.

Key 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.

Qualifications

·       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

Other Requirements

·       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.