Contract duration: until 31/08/2026
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.
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, 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)
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 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-relevantchanges
Support the preparation, linkage, and maintenance of change control documentation (TCRs/CRs) with associated technical documents
Ensure traceability of changes from requirements through qualification
Experience
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)