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