About the job
We are seeking an experienced Senior Process Engineer to join our client, a leading manufacturer of Active Pharmaceutical Ingredients (API). This role is crucial in supporting the development and optimization of manufacturing processes for clinical research, life sciences, analytical instruments, specialty diagnostics, and customer channels.
As a key member of the engineering team, you will lead process design, start-up, troubleshooting, and efficiency improvements, ensuring compliance with Good Manufacturing Practices (GMP). You will play a pivotal role in capital projects, technology transfers, equipment qualification, and process safety, contributing to the continuous improvement of the facility's operations.
This is an excellent opportunity for a highly skilled professional looking to lead innovation, mentor junior engineers, and drive process excellence in a dynamic and regulated environment.
Key Responsibilities
- Serve as the lead engineer in process design, troubleshooting, start-up, and efficiency improvements.
- Oversee capital projects and the integration of new technologies at the facility.
- Guide, train, and support junior process engineers in their professional development.
- Take responsibility for the process engineering aspects of plant cleaning procedures, setup, and validation.
- Implement modifications to equipment and manage qualification and commissioning activities in line with GMP standards.
- Play a key role in Technology Transfer initiatives, ensuring smooth transitions between clinical and commercial production.
- Drive process optimization projects to improve efficiency and performance.
- Act as a Process Safety Subject Matter Expert (SME) on assigned projects.
- Lead commissioning and qualification tasks, including User Requirement Specifications (URS), Process Flow Diagrams (PFDs), Piping & Instrumentation Diagrams (P&IDs), HAZOP assessments, and change control procedures.
- Submit project proposals for both small-scale and large-scale initiatives aimed at improving operations or addressing technical challenges.
- Identify and implement production planning enhancements to increase capacity and create opportunities for new business.
Leadership & Mentorship
- Deliver training sessions for plant personnel on new equipment and system updates.
- Provide mentorship and guidance to junior engineers, ensuring they develop the required technical skills and expertise.
- Support Process Engineering Placement Students, fostering their learning and professional growth.
- Act as a stand-in for the Process Engineering Manager when required.
- Lead investigations into quality and safety concerns within the facility.
- Take a key role in audit support, assisting with both internal and external audits.
- Host and lead customer visits to the site, ensuring professional engagement with clients.
Qualifcations/ Experience
- B.S in Mechanical Engineering or related engineering discipline with 5 or more years' experience or a related masters degree.
- Proven track record of working in a team based environment.
- Excellent Interpersonal Skills - able to express ideas and collaborate effectively with multidisciplinary teams. Be open minded with the ability to recognise good ideas.
- Innovative thinker - should be able to envisage new and better ways of doing things.
- Experience in executing complex problem solving techniques related to manufacturing/design technical issues. Good instincts and sound judgement for mechanical and structural design.
- Good understanding of Design for Manufacturing (DFM), related statistical tools and validation/verification techniques.
