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 in Switzerland.
What We Are Looking For
The Commissioning Qualification Validation (CQV) Specialist is responsible for a variety of tasks related to the validation of equipment and facilities. The role encompasses coordination during equipment installation, drafting IQ/OQ/PQ protocols, executing those protocols, 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, and Risk Assessment.
- The 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.
- You will execute IQ/OQ and PQ for equipment, systems, and utilities, documenting completed validation activities and identifying efficiencies within the validation program.
- Your tasks will also include assigned Quality Systems activities such as Document Management System, Change Control, Non-Conformities, and CAPA’s.
- You will be involved in writing and revising procedures relevant to Engineering activities and support the Engineering group in preparing validation, requalification, and maintenance programs.
Your Background and Experience Should Include
- Education Required: Bachelor’s Degree in Science or a Technical field.
- Language: Proficiency in English; German is a considerable advantage.
- Work Experience: 3-6 years in the Pharma Industry.
- Skills:
- Excellent technical writing skills, capable of thorough and accurate documentation.
- Strong written and oral communication abilities, facilitating effective interdepartmental collaboration.
- Outstanding organizational and time management skills.
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 initial phone call for an introduction!
Your Techfirm Team