The Opportunity
We are seeking a high-caliber Process Engineer to join a leading global pharmaceutical organisation. In this dynamic role, you will provide critical technical expertise to the Operations department, driving equipment efficiency, resolving complex technical challenges, and ensuring strict adherence to manufacturing schedules. You will be a key player in maintaining robust regulatory compliance while championing continuous improvement on site.
Key Responsibilities
- Technical Oversight & Troubleshooting: Provide engineering support to operational areas; lead root-cause analysis and execute corrective/preventative actions (CAPA) for process equipment issues.
- Automation & Data Integrity: Manage and optimise DCS and other process control systems, ensuring high performance, system compliance, and strict GMP data integrity.
- Continuous Improvement: Lead Lean Six Sigma initiatives and continuous improvement (CI) forums focused on process optimisation, waste reduction, and energy savings.
- Project & Tech Transfer: Progress engineering projects independently- from design through to commissioning- and support the transfer of new technologies and processes.
- Compliance: Ensure all operations strictly align with cGMP, ISO 14001, EMAS, and health, safety, and environmental legislation.
Qualifications & Experience
Essential:
- Education: B.S. in Chemical, Biochemical, or Process Engineering (or equivalent industrial experience).
- Expertise: Proven track record in a cGMP manufacturing environment, with a strong understanding of filtration, purification, equipment qualification, and process validation.
- Technical Skills: Hands-on experience with process control systems, instrumentation, and independent project delivery.
- Problem Solving: Strong analytical mindset with a minimum of a Lean Six Sigma Yellow Belt.
Preferred:
- Direct experience in drug manufacturing or a cGMP start-up environment.
- Advanced proficiency with control systems (DCS, PLC).
