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  • Recruiter: TargetRecruit Admin

CQV Engineer – 6219

 

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a CQV Engineer based in Visp, Switzerland for a 6-month contract with possible extension.

 

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.

  

Main Responsibilities:

  • 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.
  • Perform other duties as assigned.

 

 

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required.
  • Education Required: Bachelor’s Degree in Science or Technical field.
  • Language: English.
  • Work Experience: Advanced Level Pharma Industry 5-10 years.
  • 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.

 

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