We are looking for a CQV Engineer that will be responsible for the validation of equipment and facilities within a regulated pharmaceutical environment. This role involves overseeing the installation of equipment, drafting and executing IQ/OQ/PQ protocols, and documenting results in compliance with cGMP requirements. The CQV Engineer ensures that all validation processes are completed efficiently and in accordance with industry regulations.
Key Responsibilities:
- Validation Activities: Coordinate and oversee all validation activities, including Facilities, Utilities, and Validation Life Cycle processes. Draft and execute IQ, OQ, PQ protocols for equipment, systems, and utilities. Document validation results according to cGMP requirements.
- Technical Documentation: Prepare and maintain critical validation documentation including URS, DQ, FMEA, Risk Assessments, FAT, SAT, and Protocols (IQ, OQ, PQ). Write detailed reports summarizing completed validation activities.
- Efficiency and Compliance: Identify efficiencies and opportunities to improve the validation approach. Stay informed on regulatory changes that affect equipment and facility validation. Perform assigned Quality Systems tasks including document management, Change Control, Non-Conformities, and CAPAs.
- Procedure Development: Write and/or revise procedures related to engineering and validation activities.
- Support to Engineering Group: Assist the engineering group with the preparation of validation, requalification, and maintenance programs. Perform other duties as assigned.
Qualifications:
- Bachelor’s degree in a Science or Technical field OR
- 5-10 years of advanced-level experience in the pharmaceutical industry, with a focus on equipment/facility validation.
- Excellent technical writing skills, with a proven ability to document work in a thorough, accurate, and timely manner.
- Strong written and verbal communication skills, with the ability to work effectively across departments.
- Exceptional organizational and time management skills.
- In-depth understanding of cGMP guidelines and validation processes.
- Fluent in English (both written and spoken).
Practicalities:
Location: Visp, Switzerland
Employment Type: Full-time, 1-year contract with the possibility of extension
Start Date: Flexible