Equipment Engineering Technician

A fantastic opportunity has arisen for an Equipment Engineering Technician to join a leading Biotech organisation based in the Oxfordshire area. As the Equipment Engineering Technician you will be responsible for all aspects of GMP maintenance, calibration and repair on equipment at a Biotech Manufacturing facility in Hertfordshire and a Research and Development Laboratory based in Oxfordshire. It is expected that the Engineering Technician will spend 3 days on site on Oxfordshire and 2 days on site in Hertfordshire.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Equipment Engineering Technician will be varied however the key duties and responsibilities are as follows:

1. As the Equipment Engineering Technician you will ensure proper maintenance, calibration and repair of all GMP manufacturing equipment and laboratory equipment. You will maintain the preventive and predictive maintenance program, review equipment history for reliability concerns, identify reliability improvement opportunities and applications for predictive maintenance technologies to reduce maintenance costs.

2. Manage external contractors and suppliers as needed for completion of work carried out on site. Escort contractors into cleanrooms and witnesses calibration & maintenance activities, ensuring documentation is completed work orders are followed by contractors accordingly. Work internally and with external vendors to develop and maintain service contracts to support the maintenance program, including timely raising and issuing of PO's.

3. Own and maintain proper documentation for all records and logbooks in compliance with cGMP 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 cGMP, and are generated in compliance with internal procedures and statutory requirements (MHRA).

4. Assists in managing manufacturing shut-downs, and completes all assigned tasks following cGMPs, EHS and other regulations. Responsible for cGMP and non-GMP Standard Operating Procedures and job plans. Ensure that all engineering and facility 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.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Equipment Engineering Technician we are looking to identify the following on your profile and past history:

1. As the Equipment Engineering Technician you will have a technical qualification in mechanical, electrical or instrumentation engineering, such as an HND or HNC. Must have

2. Proven industry experience in cGMP pharmaceutical manufacturing and cleanroom environment. Experience in a sterile or aseptic injectable pharmaceutical manufacturing is desirable.

3. A working knowledge and practical experience with cGMP calibration and maintenance of bioprocessing equipment is essential.


Key Words: Engineer | Technician | Maintenance | Calibration | Equipment | Pharmaceutical | Biotechnology | cGMP | Bioprocess | Sterile | Aseptic | Mechanical | Electrical | Instrumentation


Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.