Technical Document Manager (m/f/d)

Contract duration: until 31.08.2026

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)