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Technical Document Manager

LocationVisp, Switzerland
Business SectorPharmaceutical
Contact email
Job ref25617
Published2 days ago

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).