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Position: Bioprocess Engineer / Technical Documentation Specialist
Location: Canton of Bern, Switzerland (on-site project)
Contract: 6+ months, Full-time
Overview:
Our client looks for a Bioprocess Engineer with expertise in technical documentation and GMP manufacturing. This role supports the standardization and optimization of bioprocessing operations and the execution of technical projects within a regulated environment.
Key Responsibilities:
* Serve as a subject matter expert for equipment and process standardization initiatives in biomanufacturing.
* Create, revise, and maintain SOPs and other GMP technical documentation to ensure compliance and operational excellence.
* Review and approve technical deliverables from project teams, representing the interests of manufacturing operations.
* Lead or participate in multidisciplinary teams for process improvement, technology implementation, and facility projects.
* Represent manufacturing operations as a technical expert during audits and inspections.
* Provide input and support for capital projects, including the design and commissioning of new or upgraded production areas.
* Manage and resolve process changes, CAPAs, and deviations in line with quality standards.
Requirements:
* Proven experience in GMP-regulated biomanufacturing.
* Experience with mammalian or mAbs or cell culture processes.
* Strong technical knowledge of bioprocessing (upstream, downstream) and manufacturing.
* Excellent technical writing and documentation skills.
* Experience with GMP and regulatory compliance.
* Project management and cross-functional team leadership.
* Familiarity with quality management systems and tools.
* Eligibility to work in the EU and willingness to relocate to Switzerland.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Engineering, Manufacturing, and Science
* Industries
Biotechnology Research and Pharmaceutical Manufacturing
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