Senior Metrology Specialist

Responsibilities

• Serve as an SME for metrology systems, calibration strategies, and measurement technologies.
• Perform and oversee complex calibrations, repairs, and equipment qualifications (IQ/OQ).
• Lead development and validation of advanced calibration methods and measurement system analysis.
• Analyze calibration and reliability data to identify trends, risks, and optimization opportunities.
• Design and implement reliability and proactive strategies to ensure equipment robustness (predictive maintenance, condition monitoring).
• Own and optimize CMMS/EAM systems, including asset strategies, KPIs, and reporting (e.g., MTBF, MTTR).
• Lead root cause investigations and implement robust corrective/preventive actions.
• Drive standardization of SOPs, work instructions, and engineering documentation.
• Act as technical lead during audits and regulatory inspections (e.g., ISO/IEC 17025, GMP, CAP, FDA).
• Manage vendor relationships, service contracts, and outsourced calibration programs.
• Lead the team in ownership and management of the temperature monitoring system.
• Lead capital projects including equipment selection, validation, and lifecycle planning.
• Provide mentorship, technical training, and career development for metrology staff.
• Collaborate with Automation Service Engineering, Quality, R&D, Manufacturing, and Facilities to align metrology with business objectives.
• Identify and implement cost-saving initiatives and process improvements.
• Understand and adhere to internal and external regulations, procedures & policies.

Qualifications

• Bachelor’s degree in Metrology, Engineering, or related field (advanced degree preferred), or equivalent experience.
• Deep expertise in metrology principles, uncertainty analysis, and calibration systems.
• Advanced knowledge of ISO/IEC 17025, GMP, and regulatory compliance frameworks.
• Strong experience in reliability engineering and asset lifecycle management.
• Proficiency with CMMS/EAM systems and data analytics tools.
• Working knowledge of Viewpoint or similar environmental monitoring systems.
• Basic troubleshooting skills related to cold storage and other laboratory equipment.
• Demonstrated leadership, mentoring, and project management experience.
• Excellent analytical, problem-solving, and communication skills.
• Experience applying 5S, Lean Manufacturing methodologies.
• Able to influence cross-functional stakeholders and drive strategic initiatives.
• Able to take part in an on-call rotation with afterhours/weekend response as needed.
• Willingness to travel up to 30% as needed.
• AI & Digital Fluency: Demonstrate curiosity, sound judgment, and the ability to critically evaluate and responsibly leverage AI-enabled tools in accordance with company policies, ethical standards, and regulatory requirements to improve the efficiency, effectiveness, and quality of work.