For one of our clients, a global pharmaceutical company, we are looking for a Senior Biotech Process Engineering Specialist.
General Information
Start date:
End date:
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
Karrierestufe
Management
Beschäftigungsverhältnis
Befristete Beschäftigung
Tätigkeitsbereich
Management und Fertigung
Branchen
Personalbesetzung und Rekrutierung