Commissioning Qualification Validation Engineer (CQV)

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)