We are partnering with a leading global life sciences company currently constructing a €330-million, state-of-the-art biopharmaceutical facility in Tralee, County Kerry. This cutting-edge, greenfield plant is designed to the highest environmental and sustainability standards and will focus on aseptic fill-finish and lyophilization manufacturing of advanced biologics (including mAbs and ADCs).
As a CQV Lead - Process Equipment, you will join the project during a critical phase of construction, commissioning, qualification, and validation. In this leadership role, you will take full oversight and technical ownership of the CQV strategy and execution for all process manufacturing equipment, driving systems through FAT/SAT, IQ, OQ, and PQ to successful site handover.
Key Responsibilities
- CQV Strategy & Leadership: Lead and oversee the CQV lifecycle for all core process equipment. Author, review, and approve critical validation documentation (including URS, System Impact Assessments, FMEAs, DQ, IQ, OQ, and PQ protocols).
- System Ownership (Process Equipment): Take complete technical leadership of process systems-including aseptic fill-finish lines, lyophilizers, formulation/compounding vessels, CIP/SIP systems, single-use systems (SUS), and visual inspection machines.
- Vendor & FAT/SAT Management: Lead vendor engagement from design review through Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT). Manage equipment vendors and contract CQV resources to meet project milestones.
- Risk-Based Validation: Drive the implementation of risk-based commissioning and qualification strategies adhering to ASTM E2500, EU Annex 1, and global regulatory standards (FDA, EMA).
- Deviation & CAPA Management: Lead technical investigations into protocol deviations, system non-conformances, and root cause analyses, implementing robust CAPAs to prevent reoccurrence.
- Cross-Functional Collaboration: Partner closely with Process Engineering, Automation, Quality Assurance (QA-V), Operations, and Project Controls to ensure seamless system commissioning, qualification, and final handover to operations.
Requirements & Qualifications
- Education: Bachelor's or Master's degree in Chemical/Process Engineering, Mechanical Engineering, Biotechnology, or a related discipline.
- Experience: 7+ years of CQV experience in the biopharmaceutical sector, with demonstrable experience leading process equipment CQV packages on major capital projects.
- Process Technical Expertise: Deep hands-on knowledge of aseptic fill-finish processing, lyophilization, formulation/compounding, CIP/SIP cycles, and isolator/RABS technology.
- Regulatory & Quality Standards: Thorough understanding of global GMP guidelines, FDA/EMA requirements, EU GMP Annex 1 (Aseptic Processing), GAMP 5, data integrity, and ASTM E2500 principles.
- Leadership & Soft Skills: Strong vendor management capability, experience guiding junior/contract engineers, excellent technical writing skills, and a proactive problem-solving mindset suited to a high-tempo greenfield environment.
