Production Engineer

PRODUCTION ENGINEER Location: Bushey Salary: £38,500 Shift: 4 on 4 off - Days and Nights We are recruiting for a Production Engineer to join a highly regulated GMP manufacturing environment. This is an excellent opportunity for a Production Engineer, Process Engineer, Manufacturing Engineer or experienced Production Technician to join a technically advanced pharmaceutical manufacturing operation. Working on a 4 on 4 off days and nights shift pattern, you will be responsible for developing a strong operational understanding of designated manufacturing processes, process flows and equipment. You will operate and support automated and semi-automated production processes while ensuring all activities are completed in compliance with cGMP, product licences, approved procedures, Health & Safety requirements and production KPIs. The role will involve working across complex manufacturing processes, including plasma processing, downstream purification, formulation and final product inspection. You will be expected to operate equipment, identify and resolve process issues, complete accurate documentation and support the delivery of production plans while maintaining strict quality and compliance standards. Non-Negotiable Requirements for the Production Engineer • Previous experience working within a GMP, pharmaceutical, biopharmaceutical, biotechnology or other highly regulated manufacturing environment • Experience working with automated or semi-automated manufacturing equipment and controlled production processes • Strong understanding of working to SOPs, cGMP requirements, quality standards and approved manufacturing procedures • Experience working to production plans, quality requirements and KPI targets • Strong problem-solving skills, with the ability to analyse process issues and troubleshoot effectively • Willingness to work a 4 on 4 off days and nights shift pattern Requirements for the Production Engineer • Develop a full understanding of designated process flows, manufacturing equipment and the operating environment • Set up and operate automated and semi-automated manufacturing equipment • Operate and troubleshoot processes including centrifugation, filtration and other designated manufacturing processes • Develop an understanding of downstream processing, including chromatography and ultrafiltration • Support plasma processing activities, including the handling and processing of frozen plasma, stripping, thawing and centrifugation operations • Carry out process formulations and ensure critical process samples are taken and submitted correctly • Support sterile transfers of final product to the aseptic filling suite in line with scheduled production plans • Set up and operate inspection equipment and carry out visual inspection of filled bottles and vials for defects • Complete and accurately document quality checks, line clearances, storage records and other critical procedures • Calculate defective product percentages and reconcile components against batch records • Ensure production and process documentation is completed accurately and on time • Maintain clear communication during cross-shift handovers to ensure processes remain compliant and controlled • Identify, investigate and escalate process or equipment issues • Support the Team Leader with specific investigations and problem-solving activities • Support continuous improvement initiatives to achieve quality and productivity targets Desirable Requirements for the Production Engineer • Experience with chromatography, ultrafiltration or centrifugation processes • Experience with gas and liquid filtration and troubleshooting filter testing • Experience with Clean-in-Place (CIP) systems