Proclinical is seeking a CQV Engineer to join our client's team on a contract basis. In this role, you will focus on the validation of equipment and facilities, ensuring compliance with cGMP requirements. Your expertise will be crucial in coordinating equipment installation and executing validation protocols.
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 and document results according to cGMP standards.
3. Engage in validation activities for facilities, utilities, and processes.
4. Prepare and manage validation documentation including URS, DQ, FMEA, and risk assessments.
5. Write reports on completed validation activities.
6. Identify efficiencies in validation programs and apply industry regulatory changes.
7. Perform quality systems activities such as document management, change control, and CAPA's.
8. Write or revise procedures related to engineering activities.
9. Support the engineering team in preparing 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 English.
13. Strong technical writing skills for thorough and accurate documentation.
14. Excellent communication skills for effective interdepartmental collaboration.
15. Strong organizational and time management abilities.