LIMS Validation & CSV Qualification Expert (GxP)

JC Automation Corp.; Rancho Cordova (CA); Hybrid; USD 120,000 - 150,000; Full time

Job summary

JC Automation Corp. is seeking a LIMS Validation and CSV Qualification Specialist to support GMP QC labs in a hybrid on-site/remote role in Rancho Cordova, CA.

The contractor will plan and execute validation activities for LabWare LIMS, including data integrity, 21 CFR 11, and GAMP 5 compliance, coordinating with Quality, IT, and client teams. Candidates should have extensive CSV experience, LabWare LIMS expertise, and a track record of delivering inspection-ready documentation.

Qualifications

• Minimum five years of CSV experience in GMP industries.
• Minimum three years with LabWare LIMS in GMP QC labs.
• Proven ability to write validation deliverables (IQ/OQ/PQ).
• Experience with data integrity and 21 CFR Part 11.

Responsibilities

• Participate in validation planning, design, testing, and readiness meetings.
• Develop and revise validation documentation, including VMP and URS.
• Create and execute qualification protocols onsite at client facilities.
• Maintain traceability matrices and test metrics.

Skills

Strong attention to detail

Excellent English communication

Independent worker

Team collaboration

Education

Chemistry degree

Biology degree

Microbiology degree

Pharmacy degree

Engineering degree

Information Systems

Tools

Kneat

HP ALM

ValGenesis

Job description

JC Automation Corp. is seeking a LIMS Validation and CSV Qualification Specialist to support GMP QC labs in a hybrid on-site/remote role in Rancho Cordova, CA.

The contractor will plan and execute validation activities for LabWare LIMS, including data integrity, 21 CFR 11, and GAMP 5 compliance, coordinating with Quality, IT, and client teams. Candidates should have extensive CSV experience, LabWare LIMS expertise, and a track record of delivering inspection-ready documentation.