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!
Your Techfirm Team