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