CSV & Equipment Compliance Leader

LGC AxoLabs; Petaluma (CA); On-site; USD 97,000 - 146,000; Full time

Job summary

LGC AxoLabs, a global life science CRO/CDMO, seeks a CSV & Equipment Compliance Manager to ensure regulatory compliance for Computer System Validation activities. You will plan CSV tasks with IT, QA, and operations, and support software validations and supplier qualifications in a GMP manufacturing setting.

Responsibilities include risk-based CSV, documentation review, and audits support, with emphasis on data integrity and regulatory alignment across the Quality Management System.

Qualifications

• 4+ years selecting, validating, and qualifying computerized systems in GMP settings (GAMP 5, EU GMP Annex 11, FDA 21 CFR Part 11).
• Bachelor’s degree or equivalent in CS/IT/Engineering/Life Sciences or related field.
• Training or certification in CSV, GAMP 5, or equivalent frameworks.
• Strong commitment to compliance, quality, and cross‑functional teamwork.

Responsibilities

• Plan and manage CSV tasks with IT, QA, and operations leads.
• Perform risk-based CSV activities per regulatory standards.
• Prepare, review, and approve CSV docs including specs, selection, qualification, and change control.
• Support software validations, equipment qualifications, and site qualification efforts.

Skills

CSV/GAMP5 knowledge

Regulatory mindset

Cross-functional collaboration

Data integrity awareness

Education

Bachelor’s degree or equivalent (CS/IT/Engineering/Life Sciences)

Tools

Unicorn

FactoryTalk

Rockwell Systems

Empower

Chromeleon

Job description

LGC AxoLabs, a global life science CRO/CDMO, seeks a CSV & Equipment Compliance Manager to ensure regulatory compliance for Computer System Validation activities. You will plan CSV tasks with IT, QA, and operations, and support software validations and supplier qualifications in a GMP manufacturing setting.

Responsibilities include risk-based CSV, documentation review, and audits support, with emphasis on data integrity and regulatory alignment across the Quality Management System.