Join Our Team as a CQV Specialist (m/w/d)
We are seeking talented individuals to become part of our dynamic team in the pharmaceutical and biotechnology sector in Switzerland.
What We Are Looking For
The CQV Specialist will be responsible for various tasks related to the validation of equipment and facilities. Key responsibilities include coordinating the installation of equipment, drafting and executing IQ/OQ/PQ protocols, and documenting results according to 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, and Risk Assessment.
- Validation documentation deliverables include URS, DQ, FMEA, Risk Assessments, FAT, SAT, and Protocols (IQ, IOQ, OQ, PQ). You will also prepare relevant validation documents.
- Execution of IQ/OQ and PQ for equipment, systems, and utilities. This includes writing reports on completed validation activities and identifying efficiencies in the validation program approach.
- Stay informed about industry regulatory changes as they pertain to equipment and facility validation.
- Perform assigned Quality Systems activities, including Document Management System, Change Control, Non-Conformities, and CAPA’s.
- Contribute to writing and/or revising procedures applicable to Engineering activities.
- Support the Engineering team in preparing the validation, requalification, and maintenance program.
Your Background and Experience Should Include
- Education: Bachelor’s Degree in a Science or Technical field.
- Language: Proficiency in English is required; German is an added advantage.
- Work Experience: 3-6 years in the Pharmaceutical Industry.
- Skills:
- Excellent technical writing abilities, with a knack for thorough, accurate documentation.
- Strong written and oral communication skills, enabling effective cross-departmental collaboration.
- Exceptional organizational and time management skills.
We invite you to Apply online using the form below. Please note that only applications matching the job profile will be considered.
We look forward to reviewing your CV and arranging an introductory phone call!
Your Techfirm Team