Commissioning Qualification Validation Engineer
For our Client in Visp we are searching for a Commissioning Qualification Validation Engineer (CQV) to carry out a variety of tasks related to the validation of equipment and facilities.
Key Responsibilities:
CQV validation activities including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis and Risk Assessment.
Coordination of the installation of equipment.
Drafting of the IQ/OQ/PQ protocols, execution of the IQ/OQ/PQ and documenting the results according cGMP requirements.
Execution of IQ/OQ and PQ for equipment, systems and utilities.
Prepare validation documentation deliverables including URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ).
Work to identify efficiencies in the validation program approach and apply lessons learned and stay informed of industry regulatory changes as it applies to equipment and 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.
Qualifications:
Education Required: Bachelor’s Degree in Science or Technical field.
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.
German mandatory (English a real plus)