Company Profile:
Our client is a well-established pharmaceutical manufacturer specializing in generic medicines, supplying regulated markets and is seeking an experienced Process Engineer on for a 12-month consignment. The site focuses on manufacturing, operating modern facilities with strong GMP standards and a culture of continuous improvement.
Job Summary:
The Process Investigation Engineer will lead and support cross-functional investigations related to manufacturing deviations, non-conformances, complaints, and quality trends within an OSD production environment. Working closely with QA, Production, Engineering, and QC, the role focuses on identifying robust root causes, implementing effective CAPAs, and supporting process improvements across operations such as blending, granulation, compression, coating, and packaging.
Responsibilities:
- Lead and support manufacturing investigations relating to deviations, non-conformances, complaints, and quality trends.
- Perform structured root cause analysis using recognised problem-solving tools including Fishbone, 5 Whys, fault tree analysis, and data trending techniques.
- Collaborate with Production, QA, QC, and Engineering teams to gather technical evidence and determine root causes.
- Define and implement technically justified CAPAs, ensuring alignment with site quality systems and regulatory expectations.
- Support CAPA effectiveness checks and continuous improvement initiatives.
- Analyse manufacturing and quality data to identify process trends and recurring issues.
- Provide technical troubleshooting support for OSD manufacturing processes including blending, granulation, compression, coating, and packaging.
- Ensure investigations are completed within required timelines and documented in accordance with GMP and internal quality procedures.
- Contribute to process improvement initiatives aimed at reducing deviations and improving process robustness.
Requirements:
- BEng in Chemical / Process Engineering or a relevant science or engineering discipline
- 3–4 years’ experience in a process engineering role within the pharmaceutical, biotech, or chemical industry
- Strong understanding of pharmaceutical manufacturing processes, particularly OSD production (blending, granulation, compression, coating, and/or packaging)
- Experience supporting or leading manufacturing investigations, deviations, and non-conformances
- Demonstrated use of root cause analysis tools such as Fishbone, 5 Whys, fault tree analysis, and data trending
- Experience defining and implementing CAPAs and supporting effectiveness checks
- Experience working cross-functionally with QA, Production, Engineering, and QC
- Strong planning, organisational, and communication skills
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