We are seeking a Metrology Project Engineer to lead and support engineering projects focused on small-scale equipment used across production, laboratory, and utility systems. The successful candidate will be responsible for developing and implementing calibration strategies, managing equipment lifecycles, driving process improvements, and ensuring compliance with cGMP, FDA, and other relevant regulatory standards.
This position requires a strong balance of technical expertise, project management capability, and a solid understanding of metrology systems within a regulated pharmaceutical environment.
Key Responsibilities
- Lead, plan, and execute metrology and calibration projects involving small-scale equipment across manufacturing, lab, and utility systems.
- Collaborate with operations, maintenance, and quality teams to ensure calibration programs meet site and regulatory requirements.
- Oversee the complete lifecycle of small equipment assets - from specification and procurement through commissioning and decommissioning.
- Develop, review, and optimize calibration procedures, frequencies, and data management processes within the site's CMMS or Metrology management platform.
- Maintain audit readiness and provide technical support during internal and external inspections related to calibration and metrology activities.
- Identify and implement continuous improvement initiatives to enhance accuracy, efficiency, and traceability within calibration processes.
- Manage and evaluate external calibration vendors, ensuring qualification and compliance with site standards.
- Prepare and maintain comprehensive technical documentation, including protocols, reports, and risk assessments.
- Ensure local metrology practices are aligned with global engineering and compliance frameworks.
Qualifications & Experience
- Bachelor's degree in Engineering (Mechanical, Electrical, Instrumentation, or related discipline).
- Minimum of 3 years' experience in metrology, calibration, or instrumentation engineering within a GMP-regulated or biopharmaceutical environment.
- Strong understanding of calibration principles, measurement uncertainty, and equipment qualification processes.
- Experience working with calibration or asset management systems (e.g., Blue Mountain, Maximo, or similar).
- Proven ability to manage multiple technical projects in a fast-paced, compliance-driven setting.
- Excellent communication, analytical, and technical writing skills.
