Senior Validation Engineer: CSV Lead for Regulated Labs

PSC Biotech® Corporation; Durham (NC); On-site; USD 110,000 - 145,000; Full time

Benefits offered by this job

Medical, Dental, and Vision coverage

401(k) and matching

PTO, Sick Time, Holidays

Education Assistance

Pet Insurance

Discounted Anytime Fitness rate

Financial Perks and Discounts

Job summary

PSC Biotech Corporation is seeking a Senior Validation Engineer to support commissioning, qualification, and validation of laboratory equipment, analytical instrumentation, and computerized systems in a regulated environment. You will lead validation lifecycle activities, develop protocols, manage risks, and ensure compliance with cGMP and data integrity.

You will mentor junior engineers, collaborate with cross-functional teams, and support audits and inspections to keep documentation

Qualifications

• 7+ years in validation, commissioning, qualification, or quality engineering within FDA-regulated settings.
• Experience with laboratory equipment qualification and analytical instrument validation.
• Strong CSV experience supporting regulated computerized systems.

Responsibilities

• Lead and execute commissioning, qualification, and validation activities for lab equipment, analytical instruments, utilities, and computerized systems.
• Develop, review, and execute Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, traceability matrices, and Validation Summary Reports.
• Author, execute, and review validation documentation within the KNEAT platform.
• Support Computer System Validation (CSV) activities and risk-based validation throughout lifecycle.
• Collaborate with cross-functional stakeholders to ensure on-time, compliant validation.
• Support deviation investigations, CAPAs, change controls, and impact assessments related to validation.
• Provide technical leadership and mentorship to junior validation engineers.
• Assist in internal and client audits and regulatory inspections; ensure inspection-ready documentation.

Skills

Validation

Commissioning

Qualification

Quality Engineering

CSV

KNEAT

cGMP

FDA 21 CFR 11

Technical Writing

Education

Bachelor's degree in Engineering, Life Sciences, Computer Science

Tools

KNEAT

Job description

PSC Biotech Corporation is seeking a Senior Validation Engineer to support commissioning, qualification, and validation of laboratory equipment, analytical instrumentation, and computerized systems in a regulated environment. You will lead validation lifecycle activities, develop protocols, manage risks, and ensure compliance with cGMP and data integrity.

You will mentor junior engineers, collaborate with cross-functional teams, and support audits and inspections to keep documentation