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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.

Key Responsibilities:

  • 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.