CQV Engineer m/f/d, Wallis Are you experienced in
GMP-regulated environments and passionate about the qualification and validation of equipment, systems, and utilities? Join an exciting project environment where you will work across the full validation lifecycle - from
URS, FAT/SAT to IQ/OQ/PQ - and contribute to high-impact engineering projects in the biotech industry!
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.
Sounds like a great job?
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