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CQV Engineer (M/F/D)
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.
Tasks:
The CQV Engineer will be involved in all 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
Qualification:
Bachelor’s Degree in Science or Technical field
German mandatory (English a real plus)
Advanced Level Pharma Industry minimum 5 years experience
Excellent technical writing skills and the ability to document all work in a thorough, accurate and timely manner
Excellent written and oral communication skills and the ability to work interdepartmentally in an effective manner to carry out daily duties
Excellent organizational and time management skills
Requirements:
Start: asap
Duration: 4 months
Capacity: 5 days per week
Location: Visp, Switzerland
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