Leads the sites metrology and equipment implementation program across analytical manufacturing facilities and safety equipment. Manages end-to-end deployment qualification calibration maintenance troubleshooting scheduling and workflow. Drafts and maintains maintenance operation and calibration documentation to meet business and regulatory needs. Provides expert guidance on asset management systems and ensures inspection readiness in a GMP environment.
Accountabilities:
Resource and Service Delivery: Ensure the right internal and external resources are in place to deliver metrology calibration and maintenance services that meet customer commitments and drive equipment reliability.
Firstline Decision Making: Troubleshoot equipment and process issues resolve scheduling and technical conflicts and escalate risks using established procedures to protect production schedules and compliance.
Technical Leadership: Provide expertise for analytical and manufacturing equipment; develop robust maintenance and calibration programs that improve uptime and data integrity.
Cross-Functional Execution: Coordinate activities with Quality Manufacturing Laboratories Facilities/Utilities and EHS to land priorities on time and sustain customer satisfaction.
Business Documentation and Analysis: Prepare business cases improvement plans investigations and metrics that inform metrology strategy lifecycle decisions and continuous improvement.
Continuous Learning and Best Practice: Maintain up-to-date knowledge of metrology standards and regulatory expectations (ICH USP EP FDA) and share best practices across teams to raise the bar.
Process Adherence and Improvement: Ensure SOPs and standard processes (Good Documentation Practice calibration/qualification maintenance change control) are followed and improved; escalate noncompliance to the right owners.
Project Scoping and Delivery: Define requirements delivery models and action plans for new equipment from initiation through IQ/OQ/PQ aligning stakeholders and timelines to deliver right-first-time qualifications.
Technology Awareness: Stay current with tools methods and asset management software; advise on adoption and integration with site systems to enhance accuracy and efficiency.
Compliance and GDP: Ensure all activities meet Health Safety and cGxP requirements; review vendor documentation for completeness and Good Documentation Practice.
Line-of-Business Support: Provide metrology support to Manufacturing and Laboratories including analytical instrument management stability chambers balances chart recorders and related systems to secure process control.
Change and Quality Management: Lead Change Controls deviations and CAPAs for metrology and facilities-related systems; maintain the validated state of qualified systems through disciplined change management.
Vendor and Contract Management: Obtain quotations raise purchase requisitions and manage service agreements for calibration maintenance and qualification services to ensure value and performance.
Asset Management: Oversee asset master data labeling and hierarchy in the CMMS/asset management system; support implementation maintenance testing and reporting to ensure data integrity and traceability.
Inspection Readiness: Maintain equipment regulatory compliance and audit readiness for internal and external inspections across maintenance calibration and instrument qualification programs.
Essential Skills/Experience
BS in Science or Engineering with 5 years relevant GMP pharmaceutical experience (or 5 years pharmaceutical experience).
Metrology experience with analytical manufacturing process facilities and safety equipment.
Experience in analytical equipment qualification and lifecycle (IQ/OQ/PQ/periodic review).
Expertise with asset management/CMMS software in the pharmaceutical industry.
Technical ability to troubleshoot and maintain equipment such as balances chart recorders and stability chambers.
Indepth understanding of ICH USP EP FDA guidance and cGXPs supporting metrology in a manufacturing setting.
Desirable Skills/Experience
Experience with change control deviations and CAPA management; familiarity with Quality Systems.
Experience presenting program metrics and status to senior leadership.
Experience with SIMCO or similar CMMS/asset management software.
Strong leadership and collaboration skills; successful delivery within a multicultural matrixed environment.
Date Posted
12-Jan-2026Closing Date
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Required Experience:
IC
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