Piper Companies is actively seeking a Lab Instrumentation Validation/CSV Specialist to join a gene therapy company undergoing a major lab transition and expansion. This role will support GMP readiness and ensure data integrity from an IT/OT and computerized systems perspective. The position is on-site in the RTP area of NC.

QUALIFICATIONS OF THE LAB INSTRUMENTATION VALIDATION/CSV SPECIALIST

• Bachelor’s degree
• 5+ years of hands-on experience with lab instrumentation validation
• Experience in pharmaceuticals, gene therapy, or medical devices preferred
• CSV experience required; CSA experience is a plus
• Comfortable in GMP or R&D environments
• Strong hands-on skills; strategic direction is already in place
• Able to work in a dynamic, evolving lab environment

• Responsible for lab instrumentation validation from the IT/OT side
• Ensure systems are functioning properly from a computerized systems perspective
• Assist with CSV instrumentation work and data integrity checks
• Collaborate with IT to ensure proper account setup and system integration
• Maintain existing lab configurations and add necessary documentation
• Help scale instrumentation of lab equipment
• Support ongoing operations of mass spectrometry systems during construction
• Work within defined rules and configurations as labs expand