Join Our Team as a CQV Specialist (m/w/d)
We are seeking new members to join our team in Switzerland, focusing on the pharmaceutical and biotechnology sector.
What We Are Looking For
The Commissioning Qualification Validation (CQV) Engineer will perform a variety of tasks related to the validation of equipment and facilities. This role involves coordinating the installation of equipment, drafting IQ/OQ/PQ protocols, executing these protocols, and documenting results in accordance with cGMP requirements.
Key Accountabilities
- Involvement in all validation activities, including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, and Risk Assessment.
- Preparation of validation documentation deliverables, which include URS, DQ, FMEA, Risk Assessments, FAT, SAT, and Protocols (IQ, IOQ, OQ, PQ).
- Execution of IQ/OQ and PQ for equipment, systems, and utilities. Writing reports on completed validation activities while identifying efficiencies in validation program approaches.
- Performing assigned Quality Systems activities including Document Management System, Change Control, Non-Conformities, and CAPAs.
- Writing and/or revising procedures relevant to Engineering activities.
- Supporting the Engineering group in the preparation of validation, requalification, and maintenance programs.
Your Background and Experience Should Include
- Education: Bachelor’s Degree in Science or a Technical field.
- Language: Proficiency in English; German is a significant advantage.
- Work Experience: 3-6 years in the pharmaceutical industry.
- Skills:
- Excellent technical writing skills with the ability to document work in a thorough, accurate, and timely manner.
- Strong written and oral communication skills for effective interdepartmental collaboration.
- Outstanding organizational and time management abilities.
If you are interested in this opportunity, please 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 organizing an initial phone call to introduce ourselves!
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