Technical Documentation Manager
We have a current opportunity for a Technical Documentation Manager on a contract basis. The position will be based in Canton Wallis. For further information about this position please apply.
Position Overview
The Technical Document Manager is responsible for coordinating the creation, adaptation, version control,and approval workflows of key project documentation throughout all project phases - from detailed design through execution and performance qualification (PQ). The scope 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.
Key Responsibilities:
- Document Control & Lifecycle Management
- Own the end-to-end lifecycle of technical project documents
- URS (User Requirement Specifications)
- TS (Technical Specifications)
- FDS (Functional Design Specifications)o P&IDs (Piping and Instrumentation Diagrams)
- Drawings, data sheets, 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)
- Initiate and manage review and approval workflows in document management systems (e.g.Documentum (DMS) or equivalent)
- Track and follow up on sign-offs and ensure timely completion of review cycles
- Ensure document traceability and audit readiness across all phases of the project
- Act as a liaison between internal departments (production, engineering, QA, validation) and external EPCM partners for technical documentation exchange
- Coordinate handover and archiving of EPCM-generated documents into internal systems
- Support alignment between CapEx documentation and OpEx procedural updates or GMP-relevant changes
- Support the preparation, linkage, and maintenance of change control documentation (TCRs/CRs) with associated technical documents
- Ensure traceability of changes from requirements through qualification
Key Requirement:
- 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 OpExprojects
- 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)
- Excellent organizational and coordination skills
- Detail-oriented and methodical approach
- Strong interpersonal communication skillsability to manage interfaces between departments andexternal stakeholders
- Fluency in English (written and spoken), German is an asset
(Please note: Only candidates with the legal right to work in Switzerland will be considered. Unfortunately, we are unable to offer permit sponsorship for this role)
FAQs
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