Jobdetails 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
mehr anzeigen 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
mehr anzeigen