Job Description

Work Schedule

Flex with On Call Duty

Environmental Conditions

Adherence 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.)

When 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.

How 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 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.

REQUIREMENTS

Education:

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

Experience & Competencies:

• 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

Additional Requirements:

• 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