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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:
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.
Familiarity with Emerson DeltaV, SIPAT and the use of automation in manufacturing process.
Technical knowledge with Biologics drug substance operations and analytical testing or process development.
Working knowledge of quality systems, including deviations and change control.
Requirements:
Start: asap
Duration: 12 months
Capacity: 5 days per week
Location: Werthenstein, Switzerland
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