Katalyst Healthcares and Life Sciences
CQV Validation Engineer
Katalyst Healthcares and Life Sciences, Holly Springs, North Carolina, United States, 27540
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:
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. Requirements:
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.
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. Requirements:
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.