· Support the execution / documentation of the site acceptance testing (SAT) and the writing of the summary report.
· Support the writing and execution of the Installation Qualification / Software Qualification (IQ/SQ) protocols and reports
· Support the writing and executions of the Operational Qualification protocols
· Support the writing and executions of the process Performance Qualification protocols
· Support the post-PQ equipment operations
· Technical training of the TBV Process Engineers, technicians and operators to the requirements of the process(es) and equipment documentation.
Work may also include supporting the generation or modification / revision of documents such as:
Process Requirements records for: User Requirements and Specifications (URS), P&ID, Installation drawings, equipment specifications, wiring diagrams, control diagrams, preventive maintenance procedures, calibration requirements/specifications, operating procedure updates.
· Process Failure Mode and Effects Analysis (pFMEA)
Manufacturing Operation Procedures (MOPs, also called Vietnam Manufacturing Operating Procedures, VMP, in TBV)