Engineering Technician (GMP Manufacturing and Lab Equipment) – Abingdon, Oxfordshire – Permanent
Nicholas Howard Limited are delighted to be recruiting for a new and exciting role as an Engineering Technician.
Reporting to the Director of Facilities (UK), this position will have a key role in supporting the facility operations by coordinating all aspects of GMP maintenance, calibration and repair to ensure daily activity is aligned to meet the facility / corporate goals and objectives. This role will partner with the Manufacturing and Quality departments at the Stevenage site as well as Scientific departments in Abingdon. This role is a mix of hands-on work, and oversight of vendors performing specialised activities.
- Ensure proper maintenance, calibration and repair of all GMP manufacturing equipment and laboratory equipment.
- Maintains the preventive and predictive maintenance program, reviews equipment history for reliability concerns, identifies reliability improvement opportunities and applications for predictive maintenance technologies to reduce maintenance costs.
- Manages outside contractors and suppliers as needed for completion of preventative maintenance, and calibration work. Escorts contractors into cleanrooms and witnesses calibration & maintenance activities, ensures documentation completed at the time of service and ensures work orders are followed by contractors.
- Service Contracts – work internally and with external vendors to develop and maintain service contracts to support the maintenance program including timely raising and issuing of POs.
- Own and maintain proper documentation for all records and logbooks in compliance with cGMP, state, and regulatory guidelines.
- Own and maintain critical asset management programme via hard copy documentation and spreadsheets for equipment identification program, calibration, and maintenance (CMMS).
- Help to ensure all documentation follows GMP, and are generated in compliance with internal procedures and statutory requirements (MHRA).
- Assists in managing manufacturing shut-downs, and completes all assigned tasks following cGMPs, EH&S and other regulations.
- Authors GMP and non-GMP Standard Operating Procedures and job plans.
- Ensure that all engineering / facilities SOPs are up to date, perform annual system review for systems, assist quality during Non-Conformance investigations, and help reach closure on Corrective Action Preventive Actions (CAPA). Supports timely closure of facility related GMP deficiencies including audit observations, corrective and preventative actions (CAPA) and deviations.
- Keep senior leaders across manufacturing, quality and facilities functions advised as to status of assignment(s) with respect to schedule, delays and adverse problems.
- Ensures that all appropriate documentation, drawings specifications are current.
- Establish and maintain positive and cooperative working relationships with other departments and facilities.
- Provide technical support to all departments within the facility and company’s other sites as requested.
- Assist with the preparation of the Operating Expense budget related to engineering and maintenance / calibration functions for following year.
- Identifies and maintain stock of critical spare parts and stand-by equipment needed to assure maximum capacity and reliability.
Qualifications & Experience:
- HNC / HND in Engineering or equivalent.
- Technical qualification in mechanical, electrical or instrumentation engineering or equivalent with a few years’ experience. Must have hands on and hands off cGMP experience in cleanrooms and associated documentation.
- Experience in a sterile / aseptic injectable Pharmaceutical manufacturing.
- Experience with and working in Clean rooms: ISO Grades 5 – 8 European grades A – D Maintenance & Calibration Management.
- Familiarity with GMP calibration and maintenance of bioprocessing equipment is needed.
- Strong knowledge of drug cGMP and regulatory issues is required.
- Excellent communication, planning and organisation skills needed.
To be considered for this position please apply below.