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Senior Process Engineer m/f/w (DE)
[17110]
PAS-X, MES, Process Engineering
The Senior Process Engineer joins the Process Engineering team supporting biologics clinical manufacturing at the MSD Werthenstein BioPharma site. The position focuses on technical process support, Manufacturing Execution System (MES) implementation and sustainment (PAS-X), and the integration of next-generation technologies into GMP manufacturing operations. This is an on-site role requiring close collaboration with manufacturing, quality, engineering, and digital teams. Project title: Senior Process Engineer m/f/w Type of employment: Payroll Industry: Pharma & Medizintechnik Skills: PAS-X,MES,Process Engineering Project start: ASAP Project duration: 12 months Location: Schachen, 6105 Werthenstein, Switzerland Tasks: ·Provide process engineering support for MES (PAS-X) implementation, configuration, and ongoing sustainment. ·Author, review, and maintain GMP-compliant SOPs and Work Instructions related to MES, electronic batch records (eBR), and process execution. ·Support eBR execution, troubleshooting, and continuous improvement activities. ·Ensure MES functionality aligns with process design, batch execution requirements, and MSD quality and compliance standards. ·Collaborate with cross-functional teams to integrate MES with manufacturing processes and business systems. ·Participate in MES design reviews, testing, and go-live readiness activities. ·Support clinical drug substance manufacturing operations, including resupply campaigns. ·Contribute to the evaluation, implementation, and qualification of new or modified equipment and processes. ·Train manufacturing and engineering personnel on new or updated systems, processes, and procedures. ·Work with Facility Management and internal teams to maintain GMP compliance through monitoring, calibration, maintenance, and certification of assigned equipment. Qualifications: ·Minimum 5 years of experience in the pharmaceutical or biotech industry. ·Experience working in GMP-regulated manufacturing environments. ·Hands-on experience with Manufacturing Execution Systems; PAS-X strongly preferred. ·Working knowledge of biologics manufacturing processes (upstream and downstream). ·Experience authoring and maintaining GMP documentation. ·Understanding of equipment qualification principles. ·Strong analytical and problem-solving skills. ·Ability to work independently and collaboratively in a fast-paced environment. ·Business-fluent English (C1) and German (B1), written and spoken.
- Provide process engineering support for MES (PAS-X) implementation, configuration, and ongoing sustainment.
- Author, review, and maintain GMP-compliant SOPs and Work Instructions related to MES, electronic batch records (eBR), and process execution.
- Support eBR execution, troubleshooting, and continuous improvement activities.
- Ensure MES functionality aligns with process design, batch execution requirements, and MSD quality and compliance standards.
- Collaborate with cross-functional teams to integrate MES with manufacturing processes and business systems.
- Participate in MES design reviews, testing, and go-live readiness activities.
- Support clinical drug substance manufacturing operations, including resupply campaigns.
- Contribute to the evaluation, implementation, and qualification of new or modified equipment and processes.
- Train manufacturing and engineering personnel on new or updated systems, processes, and procedures.
- Work with Facility Management and internal teams to maintain GMP compliance through monitoring, calibration, maintenance, and certification of assigned equipment.
- Minimum 5 years of experience in the pharmaceutical or biotech industry.
- Experience working in GMP-regulated manufacturing environments.
- Hands-on experience with Manufacturing Execution Systems; PAS-X strongly preferred.
- Working knowledge of biologics manufacturing processes (upstream and downstream).
- Experience authoring and maintaining GMP documentation.
- Understanding of equipment qualification principles.
- Strong analytical and problem-solving skills.
- Ability to work independently and collaboratively in a fast-paced environment.
- Business-fluent English (C1) and German (B1), written and spoken.
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