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
Experience with pH and conductivity monitoring and testing
Experience with liquid nitrogen systems and cryogenic freezing processes
Understanding of utilities including HVAC, WFI, purified water, demineralised water and coolant systems
Experience working with batch records, SOPs, BPRs or other controlled GMP documentation
Experience with equipment calibration, validation and maintenance requirements
Experience carrying out minor equipment maintenance tasks and hygienic component changes
Experience working in final product inspection, labelling or packaging environments
Experience with visual inspection of filled products and identifying product defects
Experience with continuous improvement, investigations and root cause analysis
The ideal industry experience for this role would be: FMCG, Food and Drink Manufacturing, Pharmaceutical, Automotive, Breweries, Dairy Plants - however if you have GMP experience please apply
Benefits
£38,500 Basic Salary
4 on 4 off Shift Pattern - Days and Nights
Highly Regulated GMP Manufacturing Environment
Company Pension
Free Parking
Career Development and Progression Opportunities
This is an excellent opportunity for a Production Engineer to join a highly regulated GMP manufacturing environment, offering a salary of £38,500 and a 4 on 4 off days and nights shift pattern. The role offers the opportunity to work across complex automated and semi-automated manufacturing processes, including plasma processing, downstream purification, formulation and final product inspection, while developing your career within a technically advanced pharmaceutical environment.
If you are interested please contact Joe McAuliffe at Pioneer Selection.
Alternatively, if you know someone who may be interested in this role, we offer a referral scheme for successful recommendations
Salary description
£38500.00 - £38500.00 per year