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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
