GMP CSV Compliance Lead - Equipment & IT

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

Job summary

LGC is seeking a CSV & Equipment Compliance Manager in California to lead regulatory compliance for Computer System Validation activities and deliver IT support in GMP environments.

You will plan CSV tasks with IT, QA, and operations, perform risk-based CSV per GAMP 5, EU GMP Annex 11, and 21 CFR Part 11, prepare documentation, and support audits. This role also covers supplier qualification, training, and QMS improvements.

Qualifications

• At least 4 years of experience selecting, validating, and qualifying computerized systems in a GMP-regulated setting, adhering to GAMP 5, EU GMP Annex 11, and FDA 21 CFR Part 11.
• Bachelor’s degree or equivalent experience (or higher) in Computer Science, Information Technology, Engineering, Life Sciences, or a related field.
• Training or certification in Computer System Validation (CSV), GAMP 5, or similar regulatory compliance frameworks.
• Strong dedication to compliance and quality standards.
• Excellent communication skills, reliability, and ability to work collaboratively in cross-functional teams.
• High sense of responsibility and structured approach to problem-solving.
• Familiarity with data integrity principles and regulatory guidelines (FDA, EMA).

Responsibilities

• Identify and plan CSV tasks in collaboration with LGC IT, Quality Assurance, and operational management team.
• Complete risk-based CSV activities following GAMP 5, EU GMP Annex 11, and FDA 21 CFR Part 11 requirements.
• Prepare, review, and approve CSV documentation, including requirements specifications, system selection, implementation, qualification, and change control.
• Coordinate and support software validations and equipment qualifications; assist in site qualification activities where CSV relevance applies.
• Act as Deputy System Administrator for computerized systems/equipment to ensure data integrity and compliance.
• Provide expert support during internal and external audits on CSV and Data Integrity topics.
• Contribute to continuous improvement of the Quality Management System and production processes.
• Support supplier qualification for CSV-related processes and services by serving as SME.
• Deliver staff training on CSV principles, processes, and guidelines.
• Provide IT support and services for desktops and instrument workstations operating in GMP-regulated environments or supporting production processes in a manufacturing setting. Participate as subject matter expert in resolving blocking issues and investigations related to computerized systems.

Skills

Communication

Cross-functional

Compliance mindset

Structured problem-solving

Data integrity awareness

Regulatory knowledge

Education

Bachelor’s degree in CS/IT/Engineering/Life Sciences

Tools

Unicorn

Factory Talk

Rockwell Systems

Empower

Chromeleon

Windows Server

Job description

LGC is seeking a CSV & Equipment Compliance Manager in California to lead regulatory compliance for Computer System Validation activities and deliver IT support in GMP environments.

You will plan CSV tasks with IT, QA, and operations, perform risk-based CSV per GAMP 5, EU GMP Annex 11, and 21 CFR Part 11, prepare documentation, and support audits. This role also covers supplier qualification, training, and QMS improvements.