Join Our Team as a CQV Specialist (m/w/d)
We are seeking enthusiastic individuals to become new members of our team in the pharmaceutical and biotechnology sector, located in beautiful Switzerland.
Role Overview
The Commissioning Qualification Validation (CQV) Engineer plays a critical role in the validation of equipment and facilities. This position encompasses a variety of responsibilities, including the coordination of equipment installation, drafting of IQ/OQ/PQ protocols, executing validation processes, and documenting outcomes 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 and management of validation documentation deliverables such as URS, DQ, FMEA, Risk Assessments, FAT, SAT, and Protocols (IQ, OQ, PQ).
- Execution of IQ/OQ and PQ for equipment, systems, and utilities, along with writing reports of completed validation activities.
- Identification of efficiencies in the validation program approach and application of lessons learned while staying informed of industry regulatory changes applicable to equipment and facility validation.
- Engagement in assigned Quality Systems activities, including Document Management Systems, Change Control, Non-Conformities, and CAPAs.
- Writing and/or revising procedures related to Engineering activities.
- Collaboration with the Engineering group to prepare the validation, requalification, and maintenance program.
Your Background and Experience
- Education Required: Bachelor’s Degree in Science or a Technical field.
- Language: Proficiency in English is essential; knowledge of German is a significant advantage.
- Work Experience: 3-6 years in the Pharma Industry.
- Skills:
- Excellent technical writing capabilities and ability to document work thoroughly, accurately, and in a timely manner.
- Strong written and oral communication skills, with the ability to collaborate effectively interdepartmentally.
- Exceptional organizational and time management skills.
To express your interest, 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 ourselves!
Your Techfirm Team