Metrology Supervisor (m/f/d)
Freelance/Contracting project Lengnau, Berne Start date: asap Reference number: 869907/1
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Responsibilities
- Lead and oversee daily metrology and calibration activities across GMP areas (manufacturing, QC, labs, utilities)
- Ensure all measuring and test equipment is calibrated and maintained in compliance with GMP, FDA, EMA, and ISO standards
- Manage the full calibration lifecycle: planning, execution, review, approval, and documentation
- Review and approve calibration certificates, OOT results, deviations, and technical assessments
- Drive and manage deviation, CAPA, and change control processes related to metrology
- Ensure data integrity according to ALCOA+ principles in all records and electronic systems
- Support internal/external audits and regulatory inspections, ensuring inspection readiness
- Collaborate with QA, Engineering, Validation, and Manufacturing on equipment qualification (IQ/OQ/PQ)
- Monitor and report KPIs (compliance, turnaround time, right-first-time performance)
- Train, mentor, and develop metrology technicians in GMP and technical competencies
Profile
- Bachelor’s degree in Engineering, Life Sciences, or a related technical field
- Experience in metrology/calibration within a GMP-regulated pharma/biotech environment
- Proven leadership or supervisory experience
- Strong knowledge of GMP regulations (21 CFR 210/211, Annex 11) and regulatory expectations
- Solid understanding of measurement uncertainty, risk-based calibration, and critical instrumentation
- Experience with computerized system validation (CSV) and ALCOA+ data integrity requirements
- Familiarity with QMS processes, including deviations, CAPA, and change control
- Strong analytical and problem-solving skills with a structured, quality-driven mindset
- Excellent communication and cross-functional collaboration skills
- Continuous improvement mindset with experience in process optimization
Benefits
- Renowned pharmaceutical company
- Attractive salary package
- HAYS Benefits