A fantastic opportunity has become available for an Engineering Manager to join a leading Biotech organisation based in the Oxfordshire area. As the Engineering Manager you will be play an integral role in managing the engineering operations by overseeing the delivery of maintenance, calibration, repairs and Capital Projects to ensure daily activity is aligned to meet the companies goals and objectives.
As the Engineering Manager you will initially be based at our clients manufacturing facility in Hertfordshire and then transition full time to the new multi-product manufacturing facility in Oxfordshire.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Engineering Manager will be varied however the key duties and responsibilities are as follows:
1. Ensure timely maintenance, calibration and repair of all equipment and systems to enable uninterrupted manufacturing with no unplanned downtime. Champion 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. Leads the development of bioprocess / utility design development, construction, commissioning of a new multi-product manufacturing facility and potentially other future facilities. Manage outside contractors and suppliers as needed for completion of projects, preventative maintenance, and calibration work.
3. Ensure that all cGMP automation equipment have the minimum documentation as per the ISPE GAMP5 guidelines. Help to ensure all documentation follows GMP, and are generated in compliance with internal procedures and statutory requirements (US FDA and ISO). Reviews and approve Standard Operating Procedures (SOPs) and job plans and assists in training development for others. Ensure that all engineering/facilities SOPs are up to date.
4. Acts as the Engineering SME in providing technical assistance and guidance to other disciplines and other departments throughout the facility. Prepares the Capital Expense (CAPEX) budget and the Operating Expense (OPEX) budget related to engineering and maintenance/calibration functions each year.
To be successful in your application to this exciting opportunity as the Engineering Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in an Engineering discipline such as a BEng in Bioprocess / Process Engineering or equivalent. Chartered Engineer status is also desirable.
2. Proven industry experience working in a sterile / aeseptic biopharmaceutical manufacturing facility is required. Previous hands on experience of calibration and maintenance of Bioprocess equipment and critical utilities.
3. You will have previous experience working in clean room environment: ISO Grades 5 8 European grades A D Maintenance & Calibration Management. Familiarity with HVAC / Clean room operation and processes. Strong knowledge of drug cGMP and regulatory issues is required.
Key Words: Engineer | Manager | Engineering Manager | Biotech | Bioprocess | Biopharmaceutical | Sterile | Aeseptic | Utilities | Manufacturing | GMP
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