· Draft documents related to validation (User Requirement Specification, Standard Operating Procedure, and Risk Assessment) and develop the Validation plan.
· Draft, execute, and close commissioning and qualification protocols (Installation Qualification, Operational Qualification, and Performance Qualification) of new and existing facilities, utilities, and equipment systems in coordination with internal and external resources.
· Draft and close final reports for the completed validation protocols.
· Perform investigation on validation protocol discrepancies to identify the root causes of validation test.
· Review and approve project documentation related to validation (URS, Technical Specifications, Functional Specifications, Validation Protocols, and Reports).
· Participate in equipment failure investigations and resolve all deviations and non-conformances reported during validation/qualification.
· Write, execute protocols for equipment validation, reviewing and analyzing data, adhering to GMP Regulations.
position requires a minimum of Bachelor’s degree in Mechanical Engineering, or
closely related field
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