Metrology Supervisor
Thermo Fisher Scientific
Metrology Supervisor
Job Description
Work ScheduleFlex with On Call DutyEnvironmental ConditionsAdherence 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.)Job DescriptionWhen 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 R&D in the industry, we give our people the resources and chances to create significant contributions to the world.DESCRIPTIONHow you will make an impact:The 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.What you will do: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 standardsOwn and manage the calibration lifecycle: scheduling, execution, review, approval, and archivalEnsure data integrity (ALCOA+) in all calibration records and electronic systemsReview and approve calibration certificates, deviations, and out-of-tolerance (OOT) investigationsInitiate and lead deviation, CAPA, and change control processes related to metrology activitiesMaintain full traceability to national/international standards (e.g., NIST)Support regulatory inspections and customer auditsEnsure metrology processes align with validated systems and computerized system validation (CSV) requirementsCollaborate 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 performanceDrive continuous improvement initiatives to enhance compliance and efficiencyTrain, qualify, and develop metrology personnel in GMP and technical competenciesAdhere to general cGMP rules, Quality policies, procedures and instruction as rolled out by the Quality function and endorsed by the site managementActively contribute to continuous quality improvement initiatives and deviation reporting and follow-upAdhere to general safety rules, policies, procedures and instructions as rolled out by the EHSS functions and endorsed by the site managementActively contribute to safety initiatives and issues as well as near miss reporting and follow-upMaintain commitment to Thermo Fisher Scientific values and adherence to ethics and legal compliance standardsTake personal accountability for presence, performance, and productivity for the achievements of defined objectivesThink and act with a customer-centric mindsetEmbrace intellectual curiosity and Practical Process Improvement (PPI)Reporting relationships:The position reports to Director, Manufacturing Engineering and interacts with Engineering, Maintenance, Manufacturing, EHSS, Quality Assurance, Service Contractors, and other team members.REQUIREMENTSEducation:Bachelor's degree in Engineering, Life Sciences, or related technical disciplineExperience & Competencies:5–8+ years of experience in metrology/calibration within a GMP-regulated pharmaceutical or biotech environmentPrior experience supervising or leading teams strongly preferredStrong knowledge of GMP regulations (21 CFR Parts 210/211, Annex 11), FDA/EMA expectationsSolid understanding of measurement uncertainty, risk-based calibration, and critical instrumentationExperience with CSV and data integrity requirements (ALCOA+)Familiarity with deviation/CAPA systems and quality management systems (QMS)Experience with electronic calibration and asset management systemsAdditional Requirements:Strong leadership and team developmentDeep understanding of GMP compliance and regulatory expectationsHigh attention to detail and documentation accuracyRoot cause analysis and problem-solving (e.g., 5 Whys, Fishbone)Cross-functional communication and stakeholder managementAudit readiness mindset
Locations
- Switzerland, Lengnau
Skills Required
- metrology/calibration within a GMP-regulated pharmaceuticalintermediate
- GMP regulationsintermediate
- CSVintermediate
- deviation/CAPA systemsintermediate
- electronic calibrationintermediate
Required Qualifications
- Bachelor's degree in Engineering, Life Sciences, or related technical discipline (degree in engineering)
- Bachelor's degree in Engineering, Life Sciences, or related technical discipline (degree in engineering)
- Experience & Competencies: (experience)
- 5–8+ years of experience in metrology/calibration within a GMP-regulated pharmaceutical or biotech environment (experience, 8 years)
- Prior experience supervising or leading teams strongly preferred (experience)
- Strong knowledge of GMP regulations (21 CFR Parts 210/211, Annex 11), FDA/EMA expectations (experience)
- Solid understanding of measurement uncertainty, risk-based calibration, and critical instrumentation (experience)
- Experience with CSV and data integrity requirements (ALCOA+) (experience)
- Familiarity with deviation/CAPA systems and quality management systems (QMS) (experience)
- Experience with electronic calibration and asset management systems (experience)
- 5–8+ years of experience in metrology/calibration within a GMP-regulated pharmaceutical or biotech environment (experience, 8 years)
- Prior experience supervising or leading teams strongly preferred (experience)
- Strong knowledge of GMP regulations (21 CFR Parts 210/211, Annex 11), FDA/EMA expectations (experience)
- Solid understanding of measurement uncertainty, risk-based calibration, and critical instrumentation (experience)
- Experience with CSV and data integrity requirements (ALCOA+) (experience)
- Familiarity with deviation/CAPA systems and quality management systems (QMS) (experience)
- Experience with electronic calibration and asset management systems (experience)
- Strong leadership and team development (experience)
- Deep understanding of GMP compliance and regulatory expectations (experience)
- High attention to detail and documentation accuracy (experience)
- Root cause analysis and problem-solving (e.g., 5 Whys, Fishbone) (experience)
- Cross-functional communication and stakeholder management (experience)
- Audit readiness mindset (experience)
- Strong leadership and team development (experience)
- Deep understanding of GMP compliance and regulatory expectations (experience)
- High attention to detail and documentation accuracy (experience)
- Root cause analysis and problem-solving (e.g., 5 Whys, Fishbone) (experience)
- Cross-functional communication and stakeholder management (experience)
- Audit readiness mindset (experience)
Responsibilities
- The 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.
- 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 (OOT) 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 instruction 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)
- 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 (OOT) 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 instruction 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)
- Reporting relationships:
- The position reports to Director, Manufacturing Engineering and interacts with Engineering, Maintenance, Manufacturing, EHSS, Quality Assurance, Service Contractors, and other team members.
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