Technical Document Manager – 6636
Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a
Technical Document Manager
for an potential project starting next month, for a
contract role of 1 year (with potential extension),
based in the
Visp
, Switzerland.
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.
Main Responsibilities
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)
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
Interface Management
Act as a liaison between internal departments (production, engineering, QA, validation) and externalEPCM 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
GMP Change Documentation
Support the preparation, linkage, and maintenance of change control documentation (TCRs/CRs) with associated technical documents
Ensure traceability of changes from requirements through qualification
Qualifications And Experience
Relevant working/residency permit or Swiss/EU-Citizenship required
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)
Key Competencies
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 skills; ability to manage interfaces between departments and external stakeholders
Fluency in English (written and spoken); German is an asset