Job Summary:
Working as a Process Engineer, you will play an integral role within the product supply unit's team, ensuring reliable supply of syringe and vial products to our patients globally. This role is for 12-months initially and involves multiple platforms for the PFS inspection, assembly, labelling, cartoning, of autoinjectors and prefilled syringes and vials. The platforms range from manual processes through to high-speed, high volume automated production lines. Excellent avenue to gain experience in the biopharmaceutical industry with an award-winning client.
Responsibilities:
1. Provide process engineering support to the Product Supply APU.
2. Support delivery of continuous improvement projects to existing equipment.
3. Work closely with various departments, such as MSAT, Technical Development, Quality Assurance, and Supply Chain.
4. Lead and coordinate elements of an automated inspection project and contribute to process engineering activities related to the development of new and existing manufacturing capacity.
5. Utilization of knowledge gained from existing manufacturing technologies to aid in the development of new technologies with the goal of implementing higher output and yield.
6. Ensure safety compliance, providing technical and engineering support for process and equipment failures, identifying, and implementing process and product improvements, supporting qualification of new products/processes, analyzing machine performance data, and managing improvement projects within budget and time constraints with a distinct focus on AVI inspection.
7. Support new product introductions and capacity expansions, including new vendor selections, maintenance planning, design changes, change controls, OEE improvement, yield improvement, etc.
8. Lead systematic technical root cause investigations.
9. Support all company safety and quality programs and initiatives.
Requirements:
10. Degree in an Engineering discipline (Mechanical, Manufacturing, Chemical, Industrial, Biomedical, etc.).
11. Experience in a GMP-regulated pharmaceutical, biotech, or medical device environment, ideally supporting sterile manufacturing or fill–finish processes.
12. Hands-on experience with automated or semi-automated equipment; exposure to PLCs, sensors, robotics, or vision systems (AVI experience desirable)
13. Strong process engineering skills, including troubleshooting, deviation investigations, CAPA, and data analysis.
14. Familiarity with qualification/validation (IQ/OQ/PQ), change control, and technical documentation.
15. Understanding of inspection, assembly, labelling, or packaging technologies for prefilled syringes, vials, or related products.
16. Experience with continuous improvement methodologies (Lean, Six Sigma, OEE) and driving process or yield improvements.
17. Ability to interpret technical documents such as engineering drawings, P&IDs, and equipment specifications.
18. Experience leading or contributing to engineering workstreams for projects such as equipment upgrades, new equipment introduction, or capacity expansion.
19. Strong communication, teamwork, and documentation skills; ability to work with MSAT, QA, TD, Supply Chain, and external vendors.
20. Strong problem-solving skills and experience with root-cause analysis tools (5 Whys, Fishbone, FMEA, etc.).
21. Proactive mindset focused on safety, quality, and continuous improvement.
22. Flexibility to support operations as needed (e.g., occasional off-hours or weekend support).
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