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Technical Document Manager a Visp, Vallese | Randstad

Bioprocess Engineer (Downstream)
- Visp, Vallese
- Temporaneo
For one of our clients, a world leader in the CDMO industry and biotechnology, we are currently looking for a Bioprocess Engineer (Downstream).General Information:Start date: 01.11.2025Duration: until 31.10.2026Workplace: VispWorkload: 100%Remote/Home Office: No, fully onsiteWorking hours: StandardOur client’s site in Visp, Switzerland is growing and for their Biologics organization, we are seeking experienced Bioprocess Engineers with significant work
15. Ottobre 2025
For one of our clients, a world leader in the CDMO industry and biotechnology, we are currently looking for a Bioprocess Engineer (Downstream).General Information:Start date: 01.11.2025Duration: until 31.10.2026Workplace: VispWorkload: 100%Remote/Home Office: No, fully onsiteWorking hours: StandardOur client’s site in Visp, Switzerland is growing and for their Biologics organization, we are seeking experienced Bioprocess Engineers with significant work
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Senior Qualifying Specialist
- Visp, Vallese
- Temporaneo
Location: Switzerland (100% on-site)Contract type: Full-timeLanguage: German (mandatory); English a strong plusThe roleJoin a growing pharmaceutical site as a CQV Engineer owning validation activities for equipment, systems and facilities. You’ll coordinate installations, author and execute IQ/OQ/PQ protocols, and deliver audit-ready documentation in line with cGMP/GxP and internal procedures.What you’ll doPlan and coordinate CQV for facilities &
14. Ottobre 2025
Location: Switzerland (100% on-site)Contract type: Full-timeLanguage: German (mandatory); English a strong plusThe roleJoin a growing pharmaceutical site as a CQV Engineer owning validation activities for equipment, systems and facilities. You’ll coordinate installations, author and execute IQ/OQ/PQ protocols, and deliver audit-ready documentation in line with cGMP/GxP and internal procedures.What you’ll doPlan and coordinate CQV for facilities &
mostra i dettagli dell'offerta
Senior Bioprocess Engineer
- Visp, Vallese
- Temporaneo
Senior Bioprocess Engineer (Biologics)Location: Visp, Switzerland — 100% on-siteFunction: Operations / Manufacturing Science & Technology (MSAT)Type: Full-time, permanent (immediate start possible)The opportunityA fast-growing biologics site is expanding its Microbial / Mammalian / BioConjugates operations. We’re looking for an experienced Senior Bioprocess Engineer who can lead change on the shopfloor—owning operational readiness, documentation updates,
13. Ottobre 2025
Senior Bioprocess Engineer (Biologics)Location: Visp, Switzerland — 100% on-siteFunction: Operations / Manufacturing Science & Technology (MSAT)Type: Full-time, permanent (immediate start possible)The opportunityA fast-growing biologics site is expanding its Microbial / Mammalian / BioConjugates operations. We’re looking for an experienced Senior Bioprocess Engineer who can lead change on the shopfloor—owning operational readiness, documentation updates,
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Dettagli di lavoro

Riepilogo

Visp, Vallese
Temporaneo

Pubblicato il 26. agosto 2025

Riferimento
23926

C

Christopher Woodward

+41 58 201 56 63

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Dettagli di lavoro

For our Client in Visp we are searching for a Technical Document Manager who is responsible for coordinating the creation, adaptation, version control, and approval workflows of key project documentation throughout all project phases.

Key Responsibilities:
...

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

Mostra di più

For our Client in Visp we are searching for a Technical Document Manager who is responsible for coordinating the creation, adaptation, version control, and approval workflows of key project documentation throughout all project phases.

Key Responsibilities:

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

Mostra di più