Join Our Team as a CQV Specialist (m/w/d)
We are seeking new team members to join us in the pharmaceutical and biotechnology sector here in Switzerland.
What We Are Looking For
The Commissioning Qualification Validation (CQV) Specialist will perform a variety of tasks related to the validation of equipment and facilities, including coordinating equipment installations, drafting IQ/OQ/PQ protocols, executing these protocols, and documenting the results in accordance with current Good Manufacturing Practices (cGMP) requirements.
Key Accountabilities
- The CQV Engineer will be involved in all validation activities including, but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Processes, GAP Analysis, and Risk Assessment.
- Validation documentation deliverables will include URS, DQ, FMEA, Risk Assessments, FAT, SAT, and Protocols (IQ, IOQ, OQ, PQ), along with the preparation of validation documents.
- Execution of IQ, OQ, and PQ for equipment, systems, and utilities, including writing reports on completed validation activities.
- Identifying efficiencies in the validation program approach and applying lessons learned while staying informed of industry regulatory changes affecting equipment/facility validation.
- Perform assigned Quality Systems activities including Document Management, Change Control, Non-Conformities, and CAPAs.
- Writing and/or revising procedures relevant to the Engineering activities.
- Support the Engineering group in preparing validation, requalification, and maintenance programs.
Your Background and Experience Should Include
- Education: Bachelor’s Degree in a Science or Technical field.
- Language: Proficiency in English; German is a plus.
- Work Experience: 3-6 years in the Pharmaceutical Industry.
- Skills:
- Excellent technical writing skills and the ability to document all work in a thorough, accurate, and timely manner.
- Strong written and oral communication skills with the ability to work interdepartmentally effectively.
- Exceptional organizational and time management skills.
We invite you to explore this exciting opportunity. 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 a first phone call for an introduction!
Your Techfirm Team