CQV Validation Engineer

Company : Katalyst HealthCares & Life Sciences

Location : Holly Springs, NC, 27540

Posted Date : 2 October 2025

Job Type : Other

Category : Mechanical Engineering

Occupation : Validation Engineer

Job Details

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.