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
#J-18808-Ljbffr