As a leading international clinical and commercial manufacturer of biologics and pharmaceuticals, Cobra Biologics offers a broad range of integrated and stand-alone contract development and manufacturing services for clinical trials and the commercial market. We take pride in manufacturing excellence and being a trusted provider, delivering what we promise and helping our customers to develop drugs for the benefit of patients.
We are currently looking to recruit a Maintenance Engineer. This position reports to the Facilities Manager. The Maintenance Engineer will ensure that all maintenance activities are completed in a timely manner, in line with Health and Safety expectations and cGMP requirements. The objective of the maintenance is to ensure that manufacturing schedules are maintained and that the manufacturing activity is run in a compliant manner.
The main duties will include:
- Ensuring plant and utilities are operating to specified parameters
- Managing and / or performing planned mechanical, electrical and instrumentation maintenance and safety checks
- Managing and / or performing daily checks on plant equipment
- Carrying out frequent system walkthroughs and reporting system status
- Ensuring all work is carried out safely and is in compliance with cGMPs, Good Engineering Practices (GEP), and with the appropriate statutory regulations
- Ensuring all documents are updated and reflect the “as built, and “as operated” status
- Managing and planning activities external contractors
- Managing and planning shutdown operations at the Keele facility
- Managing, planning and / or performing minor repairs to building fabric
Applicants will possess a BTEC in mechanical/electrical engineering or equivalent qualification, have relevant industrial experience and a broad knowledge of pharmaceutical systems. Successful applicants will be able to demonstrate strong verbal and written communication skills.
The role will involve working with all levels of internal personnel and external contractors and suppliers. Individuals should have a flexible approach to work and be available to attend out of hours call-outs.
Knowledge and experience in supporting cGMP areas, including clean manufacturing suites and laboratories, and experience of maintaining and operating cGMP area equipment, such as autoclaves, pure water/steam plant, AHUs and associated building services is essential.
A thorough Knowledge of cGMP and impact of plant operations on maintaining cGMP compliance is also desirable.