Senior Process Engineer

Job Description

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