Katalyst Healthcares and Life Sciences
Job Description:
We are seeking experienced CQV (Commissioning, Qualification, and Validation) Validation Engineers to join our team for immediate contract assignments. These roles are focused on the close-out phase of CQV activities for major capital projects within a fast-paced, regulated manufacturing environment.
Responsibilities:
We are seeking experienced CQV (Commissioning, Qualification, and Validation) Validation Engineers to join our team for immediate contract assignments. These roles are focused on the close-out phase of CQV activities for major capital projects within a fast-paced, regulated manufacturing environment.
Responsibilities:
- Close Out CQV Protocols: Finalize and close out Commissioning, Qualification, and Validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Documentation & Reporting: Write and finalize summary reports, confirm test results, and ensure all documentation is complete, accurate, and audit ready.
- System Closure: Oversee the closure of systems, ensuring all CQV activities are completed and documented according to project timelines and regulatory standards.
- RTM (Requirements Traceability Matrix): Perform verification activities and maintain RTMs to ensure all requirements are traced, tested, and documented throughout the system or process lifecycle.
- Problem Solving: Proactively identify, troubleshoot, and resolve issues that arise during the close-out process to ensure smooth project completion.
- Collaboration: Work closely with cross-functional teams, including project managers, engineers, and quality assurance, to drive project deliverables to completion.
- Proven experience in CQV close-out activities, including protocol execution and documentation for IQ, OQ, and PQ.
- Strong technical writing skills, with the ability to draft and finalize summary and test reports.
- Hands-on experience with Requirements Traceability Matrix (RTM) and verification activities in a manufacturing setting.
- Demonstrated ability to work in a fast-paced environment and deliver results under tight deadlines.
- Strong problem-solving skills and a proactive, solution-oriented mindset.
- Capital project experience is highly desirable.
- Must be able to work on-site, 5 days per week.
- Immediate availability is required.