Job Title: 2x CQV Program Managers (Contract)
Location: Benelux area and DACH.
Contract Duration: 12–36 months
Industry: Pharmaceuticals
Overview
We are seeking 2 experienced CQV (Commissioning, Qualification & Validation) Program Managers to lead a large-scale biopharmaceutical capital project. One in the Benelux region and one in the DACH region. This role is ideal for a seasoned professional who has hands-on grass-roots C&Q experience as well as demonstrated success managing complex, multi-discipline CQV programs within mega projects (>€500M or multi-train GMP facilities).
Key Responsibilities
* Program Leadership: Direct and coordinate all CQV program activities for a new-build or large-scale expansion project, ensuring alignment with overall project milestones and GMP readiness.
* CQV Strategy Development: Define and implement the overall CQV strategy, including system prioritization, risk-based qualification approaches, and alignment with regulatory and client expectations.
* Team Management: Lead a multi-functional CQV team (internal staff, EPCM, vendors, and contractors), ensuring delivery to cost, quality, and schedule.
* Stakeholder Coordination: Interface with Engineering, Construction, Quality Assurance, Manufacturing, and Regulatory teams to ensure seamless project execution.
* Schedule & Cost Control: Manage program budgets and timelines; proactively mitigate risks and implement corrective actions.
* Documentation Oversight: Approve and ensure completion of C&Q deliverables (URS, FAT, SAT, IQ, OQ, PQ), ensuring full traceability and data integrity.
* Regulatory Readiness: Support inspection readiness activities and ensure the CQV program meets EMA, FDA, and EU GMP compliance requirements.
* Continuous Improvement: Drive best practices in CQV execution, leveraging automation, digital commissioning tools, and risk-based methodologies.
Required Experience & Qualifications
* Education: Bachelor’s or master’s degree in engineering, Life Sciences, or related discipline.
* Experience: Minimum 10+ years in C&Q / CQV within the biopharmaceutical industry, including:
* Proven hands-on CQV experience (equipment start-up, FAT/SAT, IQ/OQ/PQ).
* Program-level management of large-scale (>€300M) pharmaceutical or biotech capital projects.
* Technical Knowledge:
* Strong understanding of GMP, GEP, ISPE Baseline Guides, ASTM E2500, and risk-based qualification.
* Familiarity with process equipment, utilities, cleanrooms, automation systems (DeltaV / SCADA / BMS), and CQV documentation systems.
* Leadership Skills: Exceptional communication, stakeholder management, and decision-making abilities in fast-paced project environments.
* Languages: Fluent English required; German or other EU language is an advantage.
* Eligibility: EU work authorization needed. No applicants without.