Join Our Team as a CQV Specialist (m/w/d)
We are seeking dynamic individuals to become part of our team in the pharmaceutical and biotechnology sector, based in Switzerland.
What We're Looking For
The CQV (Commissioning Qualification Validation) Specialist will be responsible for a range of activities focused on the validation of equipment and facilities. This role involves coordinating the installation of equipment, drafting IQ/OQ/PQ protocols, executing validation tests, and documenting results in accordance with cGMP requirements.
Key Accountabilities
- The CQV Engineer will engage in all validation activities, which include, but are not limited to:
- Facilities
- Utilities
- Validation Life Cycle
- Execution
- Technical Documentation
- Process
- GAP Analysis
- Risk Assessment
- Preparation and delivery of validation documentation, including URS, DQ, FMEA, Risk Assessments, FAT, SAT, and 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 incorporating industry regulatory changes as they relate to equipment and facility validation.
- Performing assigned Quality Systems activities, such as Document Management system, Change Control, Non-Conformities, and CAPA’s.
- Writing and revising procedures applicable to Engineering activities.
- Supporting the Engineering group in preparing the validation, requalification, and maintenance program.
Your Background and Experience Should Include
- Education Required: Bachelor’s Degree in a Science or Technical field.
- Language: English is essential; German is a significant plus.
- Work Experience: 3-6 years in the Pharmaceutical Industry.
- Skills:
- Excellent technical writing skills with the ability to document all work thoroughly, accurately, and in a timely manner.
- Strong written and oral communication skills, with the ability to collaborate effectively across departments.
- Exceptional organizational and time management skills.
We welcome you to apply online using the form below. Please note that only applications matching the job profile will be considered.
We look forward to reviewing your CV and arranging a first phone call to introduce ourselves!
Your Techfirm Team