Biotech and Pharmaceutical, Compensation and Benefits, Construction, Data Quality, Documentation, GMP (Good Manufacturing Practices), Gene Therapy, Instrumentation, Laboratory, Laboratory Operations, Legal, Mass Spectrometry, Medical Equipment, Operational Support, Realtime Transport Protocol, Research & Development (R&D), Strategic Planning, System Integration (SI), System Operations, Systems Administration/Management
Piper Companies is actively seeking a Lab Instrumentation Validation 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. This position is fully on-site in the RTP area of North Carolina.
Responsibilities of the Lab Instrumentation Validation Specialist:
- Lead lab instrumentation validation activities from an IT/OT perspective
- Ensure systems function properly within computerized system frameworks
- Support CSV activities and perform data integrity checks
- Partner with IT to ensure proper account setup and system integration
- Maintain current lab configurations and documentation
- Assist in scaling lab instrumentation as operations expand
- Support ongoing operations of mass spectrometry systems during construction and transition
- Work within established workflows and configurations as labs scale
Qualifications of the Lab Instrumentation Validation Specialist:
- Bachelor's degree required
- 5+ years of hands-on experience with lab instrumentation validation
- Experience in pharmaceuticals, gene therapy, or medical devices preferred
- Strong CSV experience required; CSA experience is a plus
- Experience in GMP and/or R&D environments
- Hands-on mindset with ability to operate within an established strategic framework
- Comfortable working in a dynamic, evolving lab setting
Compensation & Benefits for the Lab Instrumentation Validation Specialist:
- Pay Rate: $62-$68/hour
- Benefits: Cigna Medical, Dental, Vision, PTO, Holidays, and sick leave as required by law
Applications will be accepted at least 30 days after 9/12.
Keywords:
Lab instrumentation, laboratory systems, validation, CSV, CSA, IT/OT, computerized systems, data integrity, GMP, R&D, gene therapy, pharmaceuticals, RTP, HPLC, mass spectrometry, instrumentation scale-up
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