Production Engineer

Pioneer-Selection-Ltd; Bushey; On-site; GBP 32,725 - 44,275; Full time

Benefits offered by this job

Company Pension

Free Parking

Career Development

4 on 4 off shift

Job summary

Pioneer-Selection-Ltd is recruiting a Production Engineer for a highly regulated GMP manufacturing environment in Bushey. You will operate and support automated and semi-automated production processes while ensuring all activities comply with cGMP, product licences, approved procedures, Health & Safety standards and production KPIs.

The role includes working across complex manufacturing processes such as plasma processing, downstream purification, formulation and final product inspection,

Qualifications

• Experience in GMP/pharma or similarly regulated manufacturing environments.
• Ability to operate automated and semi-automated manufacturing equipment.
• Strong adherence to SOPs, cGMP, quality standards and procedures.

Responsibilities

• Operate and troubleshoot production processes including centrifugation, filtration, and downstream steps.
• Support plasma processing and aseptic transfer activities.
• Complete accurate documentation and quality checks; ensure batch records and inspections are compliant.
• Assist with delivering production plans and maintaining KPI targets.
• Identify, investigate and escalate process or equipment issues as needed.

Skills

GMP experience

Process engineering

Analytical problem solving

Shift coordination

Cross-functional teamwork

Tools

Automated manufacturing equipment

Centrifugation/filtration equipment

Job description

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 elevate 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.