Piper Companies
Piper Companies
is seeking a
CSV Engineer
for a next‑gen gene therapy innovator located in
Raleigh, North Carolina (NC) . The position is on‑site in the RTP area.
Responsibilities
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
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
Salary Range: $150,000 – $160,000 per year.
Benefits include sick leave (if required by law), medical, dental, vision, and 401(k) plan.
This job opens for applications on 09/15/2025. Applications 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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is seeking a
CSV Engineer
for a next‑gen gene therapy innovator located in
Raleigh, North Carolina (NC) . The position is on‑site in the RTP area.
Responsibilities
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
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
Salary Range: $150,000 – $160,000 per year.
Benefits include sick leave (if required by law), medical, dental, vision, and 401(k) plan.
This job opens for applications on 09/15/2025. Applications 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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