CQV Thermal Validation Specialist
About this role
General Information:
The Commissioning Qualification Validation engineer carries out a variety of tasks related to the validation of equipment and facilities. The scope of activities includes the coordination on the installation of equipment, drafting the IQ/OQ/PQ protocols, execution of the IQ/OQ/PQ and documenting the results according cGMP requirements.
- Location: Visp
- Start Date: ASAP
- Duration: 12 months (with a possibility for extension or a permanent position)
- Working Hours: 80 - 100%
- Prepare validation documents. Execution of IQ/OQ and PQ for equipment, systems and utilities.
Write reports of completed validation activities and/or revising procedures applicable to the Engineering activities
Work to identify efficiencies in the validation program approach.
Perform assigned Quality Systems activities including Document Management system, Change Control, Non-Conformities, and CAPA’s.
Support the Engineering group to prepare the validation, requalification, and maintenance program.
Your qualifications:
5-10 years experience in an Advanced Level Pharma Industry as a CQV specialist.
Working under GxP environment following hygiene and gowning procedures.
Expert of thermal validation for Process and Support equipment (incl. autoclaves, SIP, fridges / freezers…)
Knowledge of ellab SW solution ValSuite and the systems eVal Pro, datalogger and wired thermocouples.
Experience of preparing and revising DQ (URS, GMP-RA, uCQP…) documents and OQ risk analysis to prepare PQ
Experience of authoring and reviewing Commissioning and Qualification Summary Report and supervising its approval workflow.
Language: English and German Required.
Bachelor’s Degree in Science or Technical field.