Senior Process Engineer

For one of our clients, a global pharmaceutical company, we are looking for a Senior Biotech Process Engineering Specialist.

General Information:

• Start date: 02.03.2026
• End date: 26.02.2027
• Workplace: Schachen, Lucerne
• Workload: 100%
• Working Hours: Standard
• Home Office: Not possible, 100% on-site

About the job:

As a member of the growing Biotech Process Engineering group you will provide technical process engineering support to manufacturing operations and cross-functional initiatives, including the implementation of the Manufacturing Execution System (MES), as well as innovative processes and next-generation technologies to support development and clinical manufacturing of biologics.

Tasks & responsibilities:

• Provide process engineering support for the implementation and sustainment of the MES (PAS-X).
• Author, review, and maintain GMP-compliant Standard Operating Procedures (SOPs) and Work Instructions (WIs) related to MES usage, electronic batch records, and process execution.
• Support electronic batch record (eBR) execution, including troubleshooting and continuous improvement activities.
• Ensure alignment of MES functionality with process design, batch execution, and quality systems and compliance requirements.
• Collaborate with cross-functional teams to ensure successful MES integration with manufacturing processes and business systems.
• Contribute to MES-related design review, testing activities and go-live readiness.
• Providing support for the manufacturing of clinical supply drug substance, including resupply activities.
• Contribute to the evaluation, implementation, and qualification of new or modified equipment and processes.
• Support training of manufacturing and engineering personnel on new or updated processes, systems, and procedures.
• Collaborating with Facility Management and internal teams to maintain GMP compliance by overseeing routine monitoring, calibration, maintenance, and certification of assigned equipment.

Requirements:

• A minimum of 5 years of work experience in the pharmaceutical or biotech industry.
• Experience working with cross-functional project teams.
• Experience working in GMP-regulated manufacturing environments.
• Experience with Manufacturing Execution Systems; PAS-X experience strongly preferred.
• Working knowledge of biologics manufacturing processes (upstream and downstream).
• Experience authoring and maintaining GMP documentation.
• Understanding of general principles of equipment qualification.
• Strong analytical and practical problem-solving skills.
• Ability to think logically and remain proactive under pressure.
• Ability to work independently while contributing effectively within a team environment.
• Effective oral / written communication skills in English (C1) and German (B1).

Preferred Experience and Skills:

• Minimum of 3 years of experience with quality management and compliance systems, Working knowledge of quality auditing - preferred.
• Experience supporting MES or digital manufacturing initiatives.

Sounds interesting? Apply now - we're looking forward to receiving your applications!