Looking for a new role where engineering meets impact? This CSV Engineer role is calling your name
Proclinical is seeking a CSV Engineer to support the validation and compliance of computerized equipment and systems in a sterile pharmaceutical manufacturing environment. This role involves hands-on validation activities, ensuring adherence to regulatory and quality standards, and collaborating with cross-functional teams to maintain compliance.
Responsibilities:
1. Develop and execute validation protocols (DQ, IQ, OQ, PQ) for computerized equipment and control systems.
2. Generate and review validation documentation, including protocols, reports, and revalidation plans.
3. Provide technical expertise on current FDA and EU validation requirements, particularly for lyophilization, aseptic processing, and sterilization.
4. Participate in the change control process, advising on CSV-related matters.
5. Ensure compliance with cGMP, health, safety, and environmental regulations.
6. Troubleshoot validation issues and provide solutions during project execution.
7. Review and approve site change controls and ensure validation status aligns with regulatory expectations.
8. Collaborate with cross-functional teams to ensure project timelines and quality standards are met.
Key Skills and Requirements:
9. Degree in Science (e.g., Chemistry, Microbiology, Pharmacy) or Engineering (e.g., Chemical, Mechanical, Electrical).
10. Strong understanding of GAMP, ISPE Baseline Guides, and quality management systems.
11. Hands-on experience in validation activities within a healthcare or pharmaceutical manufacturing environment.
12. Knowledge of cGMP regulations and compliance requirements.
13. Effective communication and facilitation skills across teams and organizational levels.
14. Ability to manage projects effectively and meet key performance indicators (KPIs).
15. Problem-solving mindset with adaptability and resilience.