GMP Metrology Lead – Calibration & Compliance

3M HEALTHCARE; Lengnau; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Thermo Fisher Scientific is seeking a Metrology Supervisor to lead metrology and calibration activities within a GMP‑regulated pharmaceutical environment. This role ensures that all measuring and test equipment is compliant with regulatory requirements and supports product quality, patient safety, and data integrity.

The position oversees a team of technicians and maintains inspection readiness at all times.

Qualifikationen

• 5–8+ years of experience in metrology/calibration within a GMP-regulated pharmaceutical or biotech environment.
• Prior experience supervising or leading teams strongly preferred.
• Strong knowledge of GMP regulations (21 CFR Parts 210/211, Annex 11), FDA/EMA expectations.
• Solid understanding of measurement uncertainty, risk‑based calibration, and critical instrumentation.
• Experience with CSV and data integrity requirements (ALCOA+).
• Familiarity with deviation/CAPA systems and quality management systems (QMS).
• Experience with electronic calibration and asset management systems.
• Strong leadership and team development.
• Deep understanding of GMP compliance and regulatory expectations.
• High attention to detail and documentation accuracy.
• Root cause analysis and problem‑solving (e.g., 5 Whys, Fishbone).
• Cross‑functional communication and stakeholder management.
• Audit readiness mindset.

Aufgaben

• Lead and supervise daily metrology and calibration operations within GMP areas (manufacturing, QC, laboratories, utilities).
• Ensure all instruments and systems are calibrated and maintained in compliance with GMP, FDA, EMA, and ISO standards.
• Own and manage the calibration lifecycle: scheduling, execution, review, approval, and archival.
• Ensure data integrity (ALCOA+) in all calibration records and electronic systems.
• Review and approve calibration certificates, deviations, and out-of-tolerance investigations.
• Initiate and lead deviation, CAPA, and change control processes related to metrology activities.
• Maintain full traceability to national/international standards (e.g., NIST).
• Support regulatory inspections and customer audits.
• Ensure metrology processes align with validated systems and computerized system validation (CSV) requirements.
• Collaborate with QA, Validation, Engineering, and Manufacturing to support equipment qualification (IQ/OQ/PQ).
• Define and track KPIs related to compliance, turnaround time, and right‑first‑time performance.
• Drive continuous improvement initiatives to enhance compliance and efficiency.
• Train, qualify, and develop metrology personnel in GMP and technical competencies.
• Adhere to general cGMP rules, Quality policies, procedures and instructions as rolled out by the Quality function and endorsed by the site management.
• Actively contribute to continuous quality improvement initiatives and deviation reporting and follow‑up.
• Adhere to general safety rules, policies, procedures and instructions as rolled out by the EHSS functions and endorsed by the site management.
• Actively contribute to safety initiatives and issues as well as near miss reporting and follow‑up.
• Maintain commitment to Thermo Fisher Scientific values and adherence to ethics and legal compliance standards.
• Take personal accountability for presence, performance, and productivity for the achievements of defined objectives.
• Think and act with a customer‑centric mindset.
• Embrace intellectual curiosity and Practical Process Improvement (PPI).

Kenntnisse

Leadership

GMP compliance

Data integrity ALCOA+

Cross-functional collaboration

Regulatory knowledge

Ausbildung

Bachelor's degree in Engineering, Life Sciences, or related technical discipline

Tools

CSV systems

ALCOA+

QMS

Electronic calibration systems

Jobbeschreibung

Thermo Fisher Scientific is seeking a Metrology Supervisor to lead metrology and calibration activities within a GMP‑regulated pharmaceutical environment. This role ensures that all measuring and test equipment is compliant with regulatory requirements and supports product quality, patient safety, and data integrity.

The position oversees a team of technicians and maintains inspection readiness at all times.