The Commissioning Qualification Validation engineer carries out a variety of tasks related to the validation of equipment and facilities:
* Validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others.
* The validation documentation deliverables include URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ).
* Prepare validation documents. Execution of IQ/OQ and PQ for equipment, systems and utilities.
* Write reports of completed validation activities.
* Work to identify efficiencies in the validation program approach.
* Work to apply lessons learned and stay informed of industry regulatory changes as it applies to equipment / facility validation.
* Perform assigned Quality Systems activities including Document Management system, Change Control, Non-Conformities, and CAPA’s.
* Writing and/or revising procedures applicable to the Engineering activities.
* Support the Engineering group to prepare the validation, requalification, and maintenance program.
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