Technical Document Manager

• 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