Technical Document Manager – Pharma/Biotech (GMP Environment)
We are looking for a
Technical Document Manager
to take ownership of technical project documentation across all phases — from detailed design to execution and performance qualification (PQ). This role bridges CapEx projects with external engineering partners and OpEx improvements with internal teams, all within a regulated
GMP framework
.
Key Responsibilities
Document Control & Lifecycle Management
Manage the full lifecycle of technical documents (URS, TS, FDS, P&IDs, drawings, datasheets, vendor docs, design reviews).
Ensure compliance with GMP standards, internal procedures, and quality expectations.
Drive document creation, controlled revisions, and updates across stakeholders (engineering, QA, production, validation, EPCM).
Workflow Coordination
Initiate and track document reviews/approvals using EDMS (e.g., Documentum or similar).
Ensure timely sign-offs and audit-ready traceability at all stages.
Interface Management
Act as the key link between internal teams (production, QA, validation, engineering) and EPCM partners.
Oversee proper handover and archiving of external documentation into internal systems.
Align CapEx documentation with OpEx/GMP-relevant updates.
GMP Change Documentation
Support preparation and maintenance of change controls (CRs/TCRs) linked to technical documents.
Guarantee traceability from requirements to qualification.
Requirements
Degree in Engineering, Life Sciences (preferably biopharma), Technical Writing, or related.
3+ years' experience in a regulated GMP environment (pharma/biotech preferred).
Strong background in document management and technical documentation in CapEx/OpEx projects.
Familiar with GMP change management processes (CRs/TCRs).
Skills & Competencies
Excellent knowledge of technical documentation & engineering terminology (URS, FDS, P&ID, etc.).
Proficient with EDMS tools.
Highly organized, detail-driven, and methodical.
Strong communicator with the ability to coordinate across departments and external partners.
Fluent in English (German is a plus).