Jobdescription
For our Client in Visp we are searching for a Technical Document Manager who is responsible for coordinating the creation, adaptation, version control, and approval workflows of key project documentation throughout all project phases.
Key Responsibilities:
* Responsible for performance qualification (PQ) from detailed design through execution. This includes both CapEx-driven mechanical adaptations managed by external engineering (EPCM) partner and OpEx improvements executed by internal production teams, all within a regulated GMP framework.
* Document Control & Lifecycle Management
* Own the end-to-end lifecycle of technical project documents including, but not limited to:
* URS (User Requirement Specifications)
* TS (Technical Specifications)
* FDS (Functional Design Specifications)o P&IDs (Piping and Instrumentation Diagrams)
* Drawings, datasheets, design reviews, and vendor documentation
* Ensure compliance with internal documentation standards, GMP requirements, and quality records expectations
* Facilitate document creation, updates, and controlled revisions with relevant stakeholders(engineering, QA, production, validation, EPCM)
* Workflow Coordination: Initiate and manage review and approval workflows in document management systems (e.g.Documentum (DMS) or equivalent)
* Interface Management: Act as a liaison between internal departments (production, engineering, QA, validation) and external EPCM partners for technical documentation exchange
* GMP Change Documentation: Support the preparation, linkage, and maintenance of change control documentation (TCRs/CRs)
Qualifications:
* Degree in Engineering, Life Sciences (preferably biopharmaceuticals), Technical Writing, or related field
* 3+ years of experience in a regulated GMP environment, preferably in pharma/biotech
* Proven experience in document management or technical documentation within CapEx or OpEx projects
* Familiarity with GMP-compliant change management processes (CRs/TCRs)
* Strong knowledge of technical documentation and engineering terminology (URS, P&ID, FDS, etc.)
* Experience with electronic document management systems (EDMS) with a detail-oriented and methodical approach
* Fluency in English (written and spoken); German is an asset