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