Computer Systems Validation Engineer
About the Role:
A skilled Computer Systems Validation Engineer plays a pivotal role in ensuring the integrity of computerized equipment and control systems within our Pharmaceutical client's facility.
About the Position:
1. Validate all new computerized equipment and control systems, ensuring seamless integration into existing infrastructure.
2. Generate validation documentation (protocols/reports) and provide assistance with protocol execution for computerized equipment and systems.
3. Participate in change control processes, offering expertise on CSV issues as needed.
4. Leverage hands-on experience to develop and execute DQ, IQ, OQ, and PQ activities.
5. Maintain compliance with regulatory requirements throughout project management.
6. Design, implement, and execute validation studies for manufacturing and control equipment, focusing on critical systems and facilities to meet regulatory compliance.
7. Provide technical guidance on current US FDA and EU validation requirements.
8. Ensure continuous compliance with cGMP regulations regarding equipment and system validation status.
9. Maintain and update validation documentation through the approval and implementation of changes to relevant systems.
10. Review, approve, and ensure the execution of validation/revalidation plans.
11. Oversee site change controls and review/approve associated documentation.
12. Pursue ongoing compliance with cGMP regulations.
Requirements:
* Degree in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering (Chemical/Mechanical/Electrical)
* 3-5 years of experience working in Healthcare manufacturing environments, ideally with a focus on the pharmaceutical sector.
* 2-3 years of experience within a validation environment.
Benefits:
* Potential for up to two days of remote work per week, provided one of those working days is either Monday or Friday.