14679Permanent Competitive Site Based Hertfordshire, United Kingdom Updated on: 02-07-2025
An exciting opportunity has arisen for a Senior Process Engineer to join a leading biopharmaceutical company based in Hertfordshire.
As the Senior Process Engineer, you will be responsible for leading cross-functional engineering initiatives in support of technology transfer, scale-up, and validation for manufacturing operations in a GMP-regulated environment.
KEY DUTIES AND RESPONSIBILITIES:
The role of Senior Process Engineer will involve a range of responsibilities, including but not limited to:
Project Leadership & Technical Expertise:
- Drive cross-functional projects involving utility and process improvements, technology transfers, and new product introductions.
- Collaborate with R&D on scaling up complex lab-scale processes to commercial-scale operations.
Process & Equipment Design:
- Design and implement feasibility and conceptual studies, including vendor URSs, P&IDs, mass/heat balances, and process flow diagrams.
- Support commissioning, FATs/SATs, and validation of new equipment and processes.
Compliance & GMP:
- Evaluate processes for compliance with cGMP, regulatory requirements (FDA, EMA), and safety standards (e.g., HAZOP, ATEX).
- Support and perform risk assessments and process safety evaluations.
Troubleshooting & Continuous Improvement;
- Identify root causes of complex engineering issues and implement robust solutions.
- Propose engineering standards and best practices across the site.
ROLE REQUIREMENTS:To be successful in your application to this exciting opportunity as the Senior Process Engineer, you will need to demonstrate the following:
Essential:
- BEng or MEng in Chemical Engineering
- Experience in pharmaceutical, biopharma, or similar GMP / highly regulated industry
- Strong understanding of ICH Q8, FDA and EudraLex regulations
- Hands-on experience with commissioning, validation, and scale-up
- Competence in preparing URSs, mass/heat balances, and P&IDs
- Proficiency in HAZOP, ATEX, and process safety evaluations
Desirable:
- Chartered Chemical Engineer status (CEng)
- Experience with regulatory inspections and validation lifecycle
- Exposure to bracketing strategies in validation
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
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