Job Overview
The CSV Engineer plays a crucial role in ensuring compliance with regulatory requirements for computerised equipment and systems in sterile products manufacturing.
Key Responsibilities:
1. Validating new computerised equipment, generating documentation, and providing assistance with protocol execution.
2. Participating in the change control process to advise on CSV issues as necessary.
3. Developing and executing DQ, IQ, OQ, and PQ activities.
4. Ensuring projects are managed in compliance with legal requirements (Health & Safety, cGMP).
5. Designing, implementing, and executing validation studies for manufacturing and control equipment.
6. Providing technical assistance on current US FDA and EU validation requirements.
7. Maintaining validation documentation and ensuring compliance with cGMP at all times.
Qualifications and Skills:
* Degree in Science (Chemistry, Microbiology, or Pharmacy) or Engineering (Chemical/Mech/Elec).
* Post-graduate studies to augment primary degree.
* 3-5 years experience in Healthcare manufacturing environment, ideally pharmaceutical sector.
* 2-3 years experience in validation environment.
* Project management experience.
Benefits of Working as a CSV Engineer:
* Opportunity to work on various projects, including validation and compliance.
* Chance to develop skills in project management and quality assurance.
* Collaborative team environment.