Title: Validation Engineer (CQV)
Location: Lexington, KY Onsite
Duration: Long term
Positions: 3
Job Summary
We are seeking a Validation Engineer to support Commissioning, Qualification, and Validation (CQV) activities for utilities, process equipment, and process validation. This is a client-facing role supporting site execution and documentation, working within an established project team and reporting to a Compli Project Lead.
Key Responsibilities
• Execute CQV activities for utilities, process equipment, and process validation in a GMP environment
• Develop and complete CQV lifecycle documentation including URS/FRS, risk assessments, protocols, summary reports, deviations, and trace matrices
• Perform protocol execution and documentation for commissioning and qualification (as applicable), including data collection and review
• Reconcile and verify qualification data, investigate discrepancies, and support deviation documentation and closure
• Ensure deliverables are completed on schedule and provide accurate status updates to the project lead
• Collaborate with cross-functional stakeholders, vendors, and client representatives as needed
• Maintain compliance with site procedures, safety requirements, and applicable regulatory expectations
Required Qualifications
• Minimum 5 years of hands-on experience in Commissioning, Qualification, and Validation (CQV) of utilities, process equipment, and process validation
• Strong experience authoring and executing CQV lifecycle documents (URS/FRS, risk assessments, protocols, summary reports, deviations, trace matrices)
• Excellent verbal communication and technical writing skills
• Ability to work to project schedules and manage deliverables with timely, accurate reporting
• Professional client-facing demeanor and strong interpersonal skills
• Strong team player with experience working under a project lead structure
Preferred / Equipment Experience
• CQV experience with one or more of the following: formulation vessels, non-sterile nasal spray fill lines, nasal sprayer assembly lines, inspection equipment, packaging equipment, thermoforming equipment, autoclaves
Thanks & Regards,
Adarsh Mallik | IT Recruiter
LinkedIn | adarsh.mallik@centstone.com
CENTSTONE SERVICES
Address: 3400 State Route 35, Suite 9B, Hazlet, New Jersey, 07730 USA.