Metrology Manager
- India
نُشرت أول أمس
عن الوظيفة
Job Title: Metrology Manager
Location: Verna , Goa
About the Job
At Sanofi, we are committed to supporting a healthier future by delivering high-quality medicines and vaccines to patients around the world.
The Goa Site Engineering & Maintenance (E&M) team is responsible for ensuring the reliable, efficient and compliant operation of the site's buildings, equipment and shared utilities. The team plays a key role in supporting manufacturing operations, maintaining equipment reliability and ensuring compliance with regulatory, corporate and site requirements.
We are looking for a Metrology Manager to lead and manage metrology and calibration activities at our GMP manufacturing site in Goa. In this role, you will ensure that critical measurement systems and instruments remain accurate, reliable, traceable and compliant with applicable GMP and regulatory requirements.
You will work closely with Engineering, Quality, Validation and Manufacturing teams, while also managing external calibration partners and driving continuous improvement of the site's metrology program.
About Sanofi:
We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
Main Responsibilities
Metrology & Calibration
- Lead the site-wide metrology and calibration program for measuring and test equipment.
- Plan, schedule and coordinate calibration activities to ensure timely completion and compliance.
- Manage calibration of critical process and analytical instruments, including temperature, pressure, flow, pH, conductivity and weighing systems.
- Define and review calibration frequencies and acceptance criteria based on equipment criticality and performance.
- Maintain accurate, complete and audit-ready calibration records in the Computerized Maintenance Management System (CMMS)/SAP.
- Ensure calibration activities and records meet applicable GMP and data integrity requirements.
Vendor & External Service Management
- Coordinate with NABL-accredited calibration service providers for calibration activities.
- Review calibration certificates and ensure appropriate traceability to national/international standards.
- Support the qualification, evaluation and periodic review of external calibration service providers.
- Monitor vendor performance and ensure calibration activities are completed within defined timelines and quality standards.
GMP & Quality Compliance
- Ensure metrology activities comply with cGMP, GxP, GDP and applicable Indian and international regulatory requirements.
- Maintain continuous audit readiness for metrology and engineering activities.
- Support regulatory inspections and internal/external audits related to metrology.
- Lead or support deviation investigations, Out-of-Tolerance (OOT) investigations and CAPA related to measurement systems.
- Participate in Change Control activities impacting equipment and measurement systems.
- Partner with Quality Assurance to ensure timely implementation and closure of corrective and preventive actions.
Equipment Qualification & Validation
- Provide metrology expertise and support for IQ/OQ/PQ and equipment qualification/requalification activities.
- Support qualification of critical equipment such as autoclaves, stability chambers, incubators, freezers and temperature mapping systems.
- Provide metrology data and technical inputs for validation and qualification documentation.
- Perform or support requalification activities following equipment upgrades, modifications or changes.
Engineering & Equipment Reliability
- Support preventive maintenance activities to ensure equipment reliability and optimal performance.
- Apply technical expertise to troubleshoot measurement and equipment-related issues and minimize downtime.
- Support engineering projects and modifications by providing metrology expertise.
- Ensure all activities are performed in accordance with applicable HSE requirements and site procedures.
Documentation & Continuous Improvement
- Develop, review and update SOPs, work instructions and training materials related to metrology.
- Identify opportunities to improve the site's metrology processes, compliance and equipment reliability.
- Drive standardization and continuous improvement across calibration and metrology activities.
- Ensure timely closure of metrology-related actions and compliance commitments.
Training & People Development
- Ensure team members are trained and competent to perform metrology activities in accordance with applicable SOPs.
- Coach and support team members in implementing GMP, HSE and engineering systems.
- Promote a strong culture of compliance, quality and continuous improvement.
Key Decision-Making Responsibilities
- Provide technical input on calibration frequency and acceptance criteria based on equipment criticality and risk.
- Participate in Change Control reviews for modifications affecting measurement systems.
- Provide technical input into deviations and OOT investigations.
- Support decisions related to external calibration service providers and service quality.
- Provide metrology expertise for equipment qualification, validation and requalification activities.
About You
Education & Experience
- Bachelor's degree in Electrical & Electronics Engineering with a minimum of 5 years of metrology management experience in the pharmaceutical industry, OR
- Diploma in Electrical & Electronics Engineering with a minimum of 10 years of metrology management experience in the pharmaceutical industry.
- Strong hands-on experience in pharmaceutical metrology and calibration within a GMP manufacturing environment.
- Experience managing a site-wide calibration/metrology program is highly preferred.
Technical Skills
- Strong knowledge of metrology principles and calibration practices.
- Experience with process and analytical instruments including temperature, pressure, flow, pH, conductivity and weighing systems.
- Experience with IQ/OQ/PQ, equipment qualification and requalification.
- Knowledge of temperature mapping and critical pharmaceutical equipment.
- Experience in OOT investigations, deviations, CAPA and Change Control.
- Experience working with NABL-accredited calibration laboratories/service providers.
- Proficiency in SAP or other computerized calibration/CMMS systems.
Quality & Compliance
- Strong understanding of cGMP/GxP requirements and pharmaceutical quality systems.
- Experience supporting GMP audits and regulatory inspections.
- Strong understanding of documentation, data integrity and audit readiness requirements.
Digital & Business Skills
- Good working knowledge of MS Excel, Word and PowerPoint.
- Strong analytical, problem-solving and presentation skills.
- Good communication and stakeholder management skills.
- Ability to work effectively with Engineering, Quality, Validation and Manufacturing teams.
Languages
- Proficiency in English, with the ability to communicate effectively in both written and verbal formats.
Why This Role?
- Lead the end-to-end metrology program at a GMP manufacturing site.
- Work at the intersection of Engineering, Quality, Validation and Manufacturing.
- Gain strong exposure to GMP compliance, regulatory inspections, qualification and validation.
- Drive improvements in measurement reliability, compliance and site performance.
- Build expertise in a critical function supporting product quality and patient safety.