Job Opportunity:
We are seeking a skilled Process Specialist to join our team. As a Process Specialist, you will play a pivotal role in ensuring the reliable supply of syringe and vial products to our patients globally.
Key Responsibilities:
1. Provide process engineering support to our Product Supply unit.
2. Spearhead continuous improvement projects to existing equipment.
3. Collaborate with various departments, including MSAT, Technical Development, Quality Assurance, and Supply Chain.
4. Lead automated inspection project elements and contribute to process engineering activities for new and existing manufacturing capacity development.
5. Leverage knowledge from existing manufacturing technologies to drive the development of new technologies, focusing on higher output and yield.
6. E nsure safety compliance by providing technical support for process and equipment failures, identifying and implementing process improvements, supporting qualification of new products/processes, analyzing machine performance data, and managing improvement projects within time constraints.
7. Support new product introductions and capacity expansions, including new vendor selections, maintenance planning, design changes, change controls, OEE improvement, yield improvement, etc.
8. Conduct systematic technical root cause investigations.
9. Support all company safety and quality programs and initiatives.
Required Qualifications:
* Degree in an Engineering discipline (Mechanical, Manufacturing, Chemical, Industrial, Biomedical, etc.).
* Experience in a GMP-regulated pharmaceutical, biotech, or medical device environment, ideally supporting sterile manufacturing or fill–finish processes.
* Hands-on experience with automated or semi-automated equipment; exposure to PLCs, sensors, robotics, or vision systems.
* Strong process engineering skills, including troubleshooting, deviation investigations, CAPA, and data analysis.
* Familiarity with qualification/validation (IQ/OQ/PQ), change control, and technical documentation.
* Understanding of inspection, assembly, labelling, or packaging technologies for prefilled syringes, vials, or related products.
* Experience with continuous improvement methodologies (Lean, Six Sigma, OEE) and driving process or yield improvements.
* Ability to interpret technical documents such as engineering drawings, P&IDs, and equipment specifications.
* Experience leading or contributing to engineering workstreams for projects such as equipment upgrades, new equipment introduction, or capacity expansion.
* Strong communication, teamwork, and documentation skills; ability to work with MSAT, QA, TD, Supply Chain, and external vendors.
* Strong problem-solving skills and experience with root-cause analysis tools (5 Whys, Fishbone, FMEA, etc.).
* Proactive mindset focused on safety, quality, and continuous improvement.
* Flexibility to support operations as needed (e.g., occasional off-hours or weekend support).
About the Role:
This is an excellent opportunity to gain experience in the biopharmaceutical industry with an award-winning organization.
Contact Information:
(Not available)