Calibration and Maintenance Engineer

About the role

The Calibration and Maintenance Engineer will act as the subject‑matter expert for calibration, metrology and planned maintenance of GMP assets used in gene‑therapy manufacturing. You will ensure that all equipment is fit for use, compliant with cGMP requirements and ready for regulatory inspections.

Key responsibilities

• Define and optimise maintenance and calibration strategies for GMP equipment based on technical knowledge and best practice.
• Coordinate and approve calibration and maintenance documentation throughout the equipment lifecycle.
• Supervise internal and external teams to execute maintenance and calibration tasks in the CMMS.
• Create, review and author technical standards, service level agreements and documentation for new equipment introductions.
• Support inspection readiness and assist with regulatory audits and inspections.
• Manage quality processes such as risk assessments, change controls, CAPAs and deviations related to equipment failures.
• Ensure all work complies with GMP, data integrity and Good Documentation Practice.

Required profile

• Proven experience in calibration, metrology and planned maintenance within a GMP environment.
• Strong understanding of cGMP, data integrity and regulatory requirements for gene‑therapy manufacturing.
• Ability to work with internal and external stakeholders, including third‑party service providers.
• Excellent documentation skills and attention to health and safety standards.

Required skills

• CMMS (Computerised Maintenance Management System)
• Calibration and metrology techniques
• GMP / cGMP compliance
• Technical documentation and standards development