Join Our Team as a CQV Specialist (m/w/d)
We are seeking dynamic new members to join our team in the pharmaceutical and biotechnology sector based 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 CQV Specialist will be responsible for a variety of tasks related to the validation process, including:
- Coordinating equipment installation and drafting IQ/OQ/PQ protocols.
- Executing IQ/OQ/PQ tasks and documenting results per 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
- Prepare and deliver validation documentation such as URS, DQ, FMEA, Risk Assessments, FAT, SAT, and protocols (IQ, IOQ, OQ, PQ).
- Execute IQ/OQ and PQ for equipment, systems, and utilities, documenting completed validation activities.
- Identify efficiencies in the validation program and implement lessons learned while staying updated on regulatory changes in the industry.
- Perform assigned Quality Systems activities including Document Management System, Change Control, Non-Conformities, and CAPA management.
- Write and/or revise procedures relevant to Engineering activities.
- Support the Engineering group in preparing validation, requalification, and maintenance programs.
Your Background and Experience Should Include
- Education Required: Bachelor’s Degree in a Science or Technical field.
- Language Proficiency: English is required; German is a significant advantage.
- Work Experience: 3-6 years in the pharmaceutical industry.
- Skills:
- Exceptional technical writing skills with the capability to document all work accurately and promptly.
- Excellent written and verbal communication skills, with the ability to collaborate effectively across departments.
- Strong organizational and time management abilities.
We look forward to receiving your CV. Apply online using the form below. Please note that only applications matching the job profile will be considered.
Best regards,
Your Techfirm Team