Jobdescription
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!