Join Our Team as a CQV Specialist (m/w/d)
We are seeking dedicated individuals to become part of our team in the pharmaceutical and biotechnology sector here in Switzerland.
What We Are Looking For
The CQV Specialist is responsible for a diverse range of tasks related to the validation of equipment and facilities. Key responsibilities include coordinating equipment installation, drafting IQ/OQ/PQ protocols, executing these protocols, and documenting results in accordance with cGMP requirements.
Key Accountabilities
The CQV Engineer will engage in all validation activities, including but not limited to:
- Facilities
- Utilities
- Validation Life Cycle
- Execution
- Technical Documentation
- Process
- GAP Analysis
- Risk Assessment
The validation documentation deliverables include:
- User Requirement Specifications (URS)
- Design Qualification (DQ)
- Failure Mode and Effect Analysis (FMEA)
- Risk Assessments
- Factory Acceptance Testing (FAT)
- Site Acceptance Testing (SAT)
- Protocols (IQ, OQ, PQ)
Key tasks also involve:
- Preparing validation documents
- Executing IQ/OQ and PQ for equipment, systems, and utilities
- Writing reports of completed validation activities
- Identifying efficiencies in the validation program approach
- Performing assigned Quality Systems activities, including Document Management system, Change Control, Non-Conformities, and CAPAs
- Writing and/or revising procedures applicable to engineering activities
- Supporting the engineering group in preparing validation, requalification, and maintenance programs
Your Background and Experience
The ideal candidate will possess:
- A Bachelor’s or Master's Degree in a Science or Technical field
- Fluency in English and German
- 3-6 years of experience in the pharmaceutical industry
- Excellent technical writing skills with a commitment to thorough, accurate, and timely documentation
- Strong written and oral communication skills, capable of working effectively across departments
- Exceptional organizational and time management skills
Apply online using the form below. Please note that only applications matching the job profile will be considered.
We look forward to receiving your CV and arranging an initial phone call to introduce ourselves!
Your Techfirm Team