Senior Process Engineer (m/f/d)

Tasks :

• 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 MSD 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.

Qualification:

• 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.

• Business Fluent in English and German: Effective oral / written communication skills in English (C1). Effective oral / written communication skills in German (B1).

• Preferred:

Requirements: