ppbWork Schedule /b /ppFlex with On Call Duty /ppbEnvironmental Conditions /b /ppAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) /ppbJob Description /b /ppWhen you join us at Thermo Fisher Scientific, you'll be part of an inquisitive team that shares your passion for exploration and discovery. With revenues of more than $40 billion and the largest investment in RD in the industry, we give our people the resources and chances to create significant contributions to the world. /ppbDESCRIPTION /b /ppHow you will make an impact: /ppThe Metrology Supervisor is responsible for leading metrology and calibration activities in 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, ensures adherence to ALCOA+ principles, and maintains inspection readiness at all times. /ppWhat you will do: /pulliLead and supervise daily metrology and calibration operations within GMP areas (manufacturing, QC, laboratories, utilities) /liliEnsure all instruments and systems are calibrated and maintained in compliance with GMP, FDA, EMA, and ISO standards /liliOwn and manage the calibration lifecycle: scheduling, execution, review, approval, and archival /liliEnsure data integrity (ALCOA+) in all calibration records and electronic systems /liliReview and approve calibration certificates, deviations, and out-of-tolerance (OOT) investigations /liliInitiate and lead deviation, CAPA, and change control processes related to metrology activities /liliMaintain full traceability to national/international standards (e.g., NIST) /liliSupport regulatory inspections and customer audits /liliEnsure metrology processes align with validated systems and computerized system validation (CSV) requirements /liliCollaborate with QA, Validation, Engineering, and Manufacturing to support equipment qualification (IQ/OQ/PQ) /liliDefine and track KPIs related to compliance, turnaround time, and right-first-time performance /liliDrive continuous improvement initiatives to enhance compliance and efficiency /liliTrain, qualify, and develop metrology personnel in GMP and technical competencies /liliAdhere to general cGMP rules, Quality policies, procedures and instruction as rolled out by the Quality function and endorsed by the site management /liliActively contribute to continuous quality improvement initiatives and deviation reporting and follow-up /liliAdhere to general safety rules, policies, procedures and instructions as rolled out by the EHSS functions and endorsed by the site management /liliActively contribute to safety initiatives and issues as well as near miss reporting and follow-up /liliMaintain commitment to Thermo Fisher Scientific values and adherence to ethics and legal compliance standards /liliTake personal accountability for presence, performance, and productivity for the achievements of defined objectives /liliThink and act with a customer-centric mindset /liliEmbrace intellectual curiosity and Practical Process Improvement (PPI) /li /ulpReporting relationships: /ppThe position reports to Director, Manufacturing Engineering and interacts with Engineering, Maintenance, Manufacturing, EHSS, Quality Assurance, Service Contractors, and other team members. /ppbREQUIREMENTS /b /ppEducation: /pulliBachelor's degree in Engineering, Life Sciences, or related technical discipline /li /ulpExperience Competencies: /pulli5–8+ years of experience in metrology/calibration within a GMP-regulated pharmaceutical or biotech environment /liliPrior experience supervising or leading teams strongly preferred /liliStrong knowledge of GMP regulations (21 CFR Parts 210/211, Annex 11), FDA/EMA expectations /liliSolid understanding of measurement uncertainty, risk-based calibration, and critical instrumentation /liliExperience with CSV and data integrity requirements (ALCOA+) /liliFamiliarity with deviation/CAPA systems and quality management systems (QMS) /liliExperience with electronic calibration and asset management systems /li /ulpAdditional Requirements: /pulliStrong leadership and team development /liliDeep understanding of GMP compliance and regulatory expectations /liliHigh attention to detail and documentation accuracy /liliRoot cause analysis and problem-solving (e.g., 5 Whys, Fishbone) /liliCross-functional communication and stakeholder management /liliAudit readiness mindset /li /ulpThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. /p /p #J-18808-Ljbffr
Metrology Supervisor Arbeitgeber: ThermoFisher Scientific
Thermo Fisher Scientific ist ein hervorragender Arbeitgeber, der seinen Mitarbeitern in der Pharma- und Biotech-Branche eine dynamische und unterstützende Arbeitsumgebung bietet. Mit einem starken Fokus auf persönliche und berufliche Weiterentwicklung sowie einer Kultur der Zusammenarbeit und Innovation, haben Sie die Möglichkeit, bedeutende Beziehungen zu Kunden aufzubauen und an vorderster Front der wissenschaftlichen Fortschritte zu arbeiten. Darüber hinaus profitieren Sie von flexiblen Arbeitsmodellen und einem internationalen Netzwerk, das Ihre Karrierechancen erheblich erweitert.
