CSV Engineer

Piper Companies is seeking a CSV Engineer for a next-gen gene therapy innovator located in Raleigh, North Carolina (NC). The CSV Engineer will ensure successful validation and integration of lab systems and instrumentation within the OT Labs team. This is an on-site position in the RTP area of North Carolina.

Responsibilities of the CSV Engineer:

• Support validation activities for lab systems within the OT Labs team.
• Manage the full system development life cycle, from impact assessment through validation reporting.
• Execute validation protocols for LIMS (new implementation) and chromatography data systems (expansion).
• Coordinate validation schedules around active instrumentation use and lab downtime.
• Collaborate with cross-functional teams (QA, QC Micro, IT/OT, MS&T) to ensure smooth execution.
• Travel occasionally to multiple lab and manufacturing sites as needed.

Qualifications for the CSV Engineer:

• 1+ year of experience validating LIMS or chromatography data systems (e.g., Chromeleon, Empower).
• 5+ years of CSV/CSA experience as a core function of the role.
• Strong understanding of computerized instrument validation processes.
• Experience owning components of enterprise system validation (e.g., QMS, ERP, MES, EBR).
• Background in automation or instrumentation with CSV exposure is a plus.

Compensation for the CSV Engineer:

• Salary Range: $150,000-160,000/year
• Comprehensive Benefits: Sick leave if required by law, medical, dental, vision, 401K

This job opens for applications on 09/15/2025. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords: CSV Engineer, Computer System Validation, CSA, LIMS, Chromeleon, Empower, chromatography data systems, system development life cycle, IQ, OQ, PQ, validation protocols, enterprise systems, QMS, ERP, MES, EBR, lab systems, OT Labs, instrumentation, automation, cross-functional collaboration, QA, QC Micro, IT/OT, MS&T, lab downtime coordination, site travel

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