Process Engineer Pharmaceutical Manufacturing (GMP Environment)
Are you a process engineer ready to make a real impact in the pharmaceutical industry? We are working with a high-profile client based in Hertfordshire who help deliver life-saving therapies to patients around the world.
We re looking for a Process Engineer with strong technical and regulatory knowledge to support and improve pharmaceutical manufacturing processes in a highly regulated GMP environment.
About the Role
As Process Engineer, and a key member of a well respected and hard working engineering team, you will:
Support the production of biopharmaceutical products by driving process improvements and equipment optimization.
Contribute to rare and exciting cross-functional projects including technology transfers, utility improvements, and new product introductions.
Ensure processes meet regulatory, safety, and quality standards while identifying opportunities for innovation and efficiency.
Develop and scale lab-based processes into full-scale manufacturing in collaboration with R&D.
Design and review process documents such as mass/heat balances, P&IDs, URS, commissioning plans, and validation documentation.
Troubleshoot technical issues and perform root cause analysis to ensure process reliability.
Support capital projects including estimating budgets and overseeing equipment installation and commissioning.
Conduct risk assessments, HAZOP studies, and ensure compliance with HSE and GMP standards.
Provide process safety support, ensuring new or modified processes are safe and compliant.
Author and maintain engineering documentation, protocols, reports, and SOPs with minimal supervision.
Train team members and assess trainees on equipment and process changes.
Play a leading role in technical transfers and support validation and qualification activities.
Skills and Experience
Qualification in Chemical Engineering or similar.
Proven experience in a GMP-regulated pharmaceutical or biopharmaceutical manufacturing environment. Similar related industries will also be considered - e.g. fine chemicals, food.
Experience with commissioning of process equipment (e.g., pumps, filters, vessels).
Ability to specify and design complex equipment and utilities.
Skilled in risk assessment, HAZOP, ATEX compliance, and UK health & safety regulations.
Self-starter with excellent documentation and project management skills.
You will require your own vehicle in order to access the facility.