Lab Instrumentation CSV Engineer

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.

Responsibilities of the Lab Instrumentation Validation/CSV Specialist:

• 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
  
  

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
  
  

Compensation of the Lab Instrumentation Validation/CSV Specialist:

Bill Rate: $62-$68/hr

Benefits: Cigna Medical, Dental, Vision, PTO, Holidays, and sick leave as required by law

Keywords

Lab Instruments, lab systems, validation, CSV, CSA, IT/OT, computerized systems, data integrity, GMP, R&D, gene therapy, pharma, pharmaceuticals, laboratory systems, RTP, HPLC, mass spectrometry, Slavia, Hopson Road, GMP readiness, instrumentation scale-up

Applications will be accepted at least 30 days after 9/12.