Join Our Team as a CQV Specialist (m/w/d)
We are seeking new members to become part of our dynamic team in the pharmaceutical and biotechnology sector here in Switzerland. As a CQV Specialist, you will play a crucial role in ensuring the quality and compliance of our equipment and facilities.
What We Are Looking For
The Commissioning Qualification Validation (CQV) Engineer will carry out a variety of tasks related to the validation of equipment and facilities. Key responsibilities include coordinating equipment installations, drafting IQ/OQ/PQ protocols, executing validations, and documenting results in accordance with cGMP requirements.
Key Accountabilities
- Participate in all validation activities, including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, and Risk Assessment.
- Deliver validation documentation including URS, DQ, FMEA, Risk Assessments, FAT, SAT, and various protocols (IQ, IOQ, OQ, PQ). Prepare validation documents as necessary.
- Execute IQ/OQ and PQ for equipment, systems, and utilities while documenting completed validation activities. Identify efficiencies in the validation approach and apply lessons learned by staying informed of industry regulatory changes related to equipment and facility validation.
- Perform assigned Quality Systems activities, including Document Management System, Change Control, Non-Conformities, and CAPAs.
- Draft or revise procedures applicable to Engineering activities.
- Support the Engineering group in preparing validation, requalification, and maintenance programs.
Background and Experience
- Education Required: Bachelor’s Degree in a Science or Technical field.
- Language: English required; German is a plus.
- Work Experience: 3-6 years in the pharmaceutical industry.
- Skills:
- Excellent technical writing skills, with the ability to document all work thoroughly, accurately, and in a timely manner.
- Strong written and oral communication skills, with an ability to work effectively across departments.
- Outstanding organizational and time management skills.
If you are interested in this 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 organizing a first phone call to introduce you to our team!
Your Techfirm Team