Metrology Supervisor

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.

DESCRIPTION

How you will make an impact:

The 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 (, 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 (, 5 Whys, Fishbone)

• Cross-functional communication and stakeholder management

• Audit readiness mindset