CQV Engineer (m/f/d)

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.