Production Engineer

Pioneer Selection Ltd; Bushey; On-site; GBP 34,650 - 42,350; Full time

Benefits offered by this job

Free Parking

Company Pension

Career Development and Progression

4 on 4 off Shift Pattern - Days and N+

Salary £38,500

Job summary

Pioneer Selection Ltd in Bushey is recruiting a Production Engineer to join a highly regulated GMP pharmaceutical manufacturing operation. You will work on a 4 on 4 off days and nights shift, operating automated and semi-automated production processes and supporting process development.

The role requires experience in GMP, validated manufacturing, and the ability to document activities, troubleshoot issues, and contribute to achieving production KPIs while maintaining quality and compliance

Qualifications

• Experience in GMP/pharma manufacturing environments.
• Experience with automated or semi-automated manufacturing equipment.
• Strong understanding of SOPs, cGMP, quality standards and procedures.
• Experience working to production plans, quality requirements and KPI targets.
• Willingness to work a 4 on 4 off days and nights shift pattern.

Responsibilities

• Develop a full understanding of designated processes, equipment and 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 understanding of downstream processing including chromatography and ultrafiltration.
• Support plasma processing activities, handling and processing of frozen plasma and related steps.
• Carry out process formulations and ensure critical samples are taken and submitted correctly.
• Support sterile transfers to the filling suite in line with production plans.
• Complete documentation and quality checks and maintain records.

Skills

GMP experience

Problem solving

Documentation accuracy

Cross-shift communication

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

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.