Join Our Team as a CQV Specialist (m/w/d)
We are seeking dedicated individuals to become part of our dynamic team in the pharmaceutical and biotechnology sector here in Switzerland.
What We Are Looking For
The Commissioning Qualification Validation (CQV) Specialist will carry out a variety of tasks related to the validation of equipment and facilities. The responsibilities include coordinating the installation of equipment, drafting IQ/OQ/PQ protocols, executing these protocols, and documenting results in compliance with cGMP requirements.
Key Accountabilities
- The CQV Engineer will be engaged in all validation activities, which encompass, but are not limited to:
- Facilities
- Utilities
- Validation Life Cycle
- Execution
- Technical Documentation
- Process
- GAP Analysis
- Risk Assessment
- The validation documentation deliverables will include
- URS (User Requirement Specification)
- DQ (Design Qualification)
- FMEA (Failure Mode and Effects Analysis)
- Risk Assessments
- FAT (Factory Acceptance Testing)
- SAT (Site Acceptance Testing)
- Protocols (IQ, IOQ, OQ, PQ)
- Execute IQ/OQ and PQ for equipment, systems, and utilities, while writing reports of completed validation activities.
- Identify efficiencies in the validation program approach, applying lessons learned and keeping abreast of industry regulatory changes pertinent to equipment and facility validation.
- Perform assigned Quality Systems activities including Document Management System, Change Control, Non-Conformities, and CAPA (Corrective and Preventive Actions).
- Write and/or revise procedures relevant to Engineering activities.
- Support 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: Proficient in English; German is a significant advantage.
- Work Experience: 3-6 years in the Pharmaceutical Industry.
- Skills:
- Excellent technical writing skills and the ability to document work comprehensively and accurately.
- Strong written and oral communication skills with a collaborative approach to interdepartmental work.
- Exceptional organizational and time management abilities.
If you believe you are a suitable match for this role, 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 introductory phone call!
Your Techfirm Team