CQV Specialist / CQV Specialistess

Join Our Team as a CQV Specialist (m/w/d)

We are seeking new members to enhance our team in the pharmaceutical and biotechnology sector here in Switzerland. As a CQV Specialist, you will play a crucial role in ensuring the validation of equipment and facilities.

What We Are Looking For

The Commissioning Qualification Validation (CQV) Engineer will carry out a variety of tasks related to the validation processes. This includes coordinating equipment installation, drafting IQ/OQ/PQ protocols, executing validations, and documenting results in accordance with cGMP requirements.

Key Accountabilities

• The CQV Engineer will be involved in validation activities, including but not limited to:
  • Facilities
  • Utilities
  • Validation Life Cycle
  • Execution
  • Technical Documentation
  • Process
  • GAP Analysis
  • Risk Assessment
• Preparation of validation documentation deliverables, including:
  • URS
  • DQ
  • FMEA
  • Risk Assessments
  • FAT
  • SAT
  • Protocols (IQ, OQ, PQ)
• Execution of IQ/OQ and PQ for equipment, systems, and utilities, along with writing reports on completed validation activities.
• Identifying efficiencies in the validation program approach and applying lessons learned while staying informed of regulatory changes applicable to equipment and facility validation.
• Performing assigned Quality Systems activities, including Document Management, Change Control, Non-Conformities, and CAPAs.
• Writing and revising procedures relevant to engineering activities.
• Supporting the Engineering group in preparing validation, requalification, and maintenance programs.

Your Background and Experience Should Include

• Education: Bachelor’s Degree in Science or a Technical field.
• Language: Proficiency in English; German is a plus.
• Work Experience: 3-6 years in the Pharma Industry.
• Skills:
  • Excellent technical writing skills, with the ability to document thoroughly, accurately, and in a timely manner.
  • Strong written and oral communication skills, with the capacity to work effectively across departments.
  • Outstanding organizational and time management skills.

Apply online using the form below. Only applications matching the job profile will be considered. We look forward to reviewing your CV and organizing a first phone call to introduce you to our team!

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