Ready to validate the future of pharma? Proclinical is looking for a CQV Engineer to drive excellence for a diabetes-focused role within the pharmaceutical industry.
You will play a crucial role in ensuring equipment and facilities meet regulatory standards through comprehensive validation processes. This position requires a proactive approach to managing validation activities and documentation in line with cGMP requirements.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
1. Coordinate installation of equipment and draft IQ/OQ/PQ protocols.
2. Execute IQ/OQ/PQ processes and document results.
3. Engage in validation activities for facilities, utilities, and processes.
4. Prepare and manage validation documents including URS, DQ, FMEA, and risk assessments.
5. Conduct GAP analysis and risk assessments.
6. Identify efficiencies in validation programs and apply industry regulatory changes.
7. Perform quality systems activities such as document management, change control, and CAPA.
8. Write and revise procedures related to engineering activities.
9. Support engineering group in validation, requalification, and maintenance programs.
10. Perform other duties as assigned.
Key Skills and Requirements:
11. Bachelor's Degree in Science or Technical field.
12. Proficiency in German; English is advantageous.
13. Strong technical writing skills for thorough documentation.
14. Effective written and oral communication skills for interdepartmental collaboration.
15. Excellent organizational and time management abilities.