In this role, you will oversee the management and coordination of technical project documents across all project phases, ensuring compliance and traceability. You will serve as a key link between internal teams and external partners, facilitating smooth document workflows within a regulated GMP environment. Your work will support both capital investments and operational improvements, maintaining high standards of quality and accuracy.

Start Date: ASAP

Duration: 12 Months 

Place of Work: Visp

Key Responsibilities

  • Manage the complete lifecycle of technical project documents, including User Requirement Specifications (URS), Technical Specifications (TS), Functional Design Specifications (FDS), Piping and Instrumentation Diagrams (P&IDs), drawings, datasheets, design review reports, and vendor documentation
  • Ensure all documentation complies with internal standards, Good Manufacturing Practice (GMP) requirements, and quality record expectations
  • Facilitate the creation, updating, and controlled revision of documents in collaboration with relevant stakeholders such as engineering, quality assurance, production, validation, and external EPCM partners
  • Initiate and oversee review and approval processes within document management systems like Documentum or similar tools
  • Monitor progress, follow up on sign-offs, and ensure review cycles are completed in a timely manner
  • Maintain document traceability and readiness for audits throughout all project phases
  • Serve as the primary contact between internal departments—including production, engineering, QA, and validation—and external EPCM partners for technical document exchanges
  • Coordinate the transfer and archiving of EPCM-produced documents into internal systems
  • Support alignment of capital expenditure documentation with operational procedures and GMP-related updates
  • Assist in the preparation, linkage, and maintenance of change control documentation such as Technical Change Requests (TCRs) and Change Requests (CRs), ensuring they are connected to relevant technical documents
  • Ensure all modifications are traceable from initial requirements through to qualification activities

Candidate Profile

  • Bachelor’s degree in Engineering, Life Sciences, Technical Writing, or a related field
  • At least three years of experience working within a regulated GMP environment, preferably in pharma or biotech sectors
  • Demonstrated experience in managing technical documentation for CapEx or OpEx projects
  • Familiarity with GMP-compliant change management processes and documentation
  • Strong understanding of technical documentation such as URS, P&ID, FDS, and related engineering terminology
  • Proficiency with electronic document management systems
  • Excellent organizational skills, detail-oriented, and methodical
  • Strong communication skills with the ability to coordinate across departments and external partners

  • Fluent in English, both written and spoken; German language skills are an advantage

     

Job ID 41181093