Hiring: CSV & Equipment Compliance Manager Company: LGC Location: Petaluma, CA Job Posted Time: 2026-09-10 11:30:03 Employment Type: Contract Target Skills & Keywords : Embedded Systems, Quality Assurance, Regulatory Compliance, Windows Server About the job Experience: •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. •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. Required Skills: •This is an outstanding chance to become part of LGC, a company known for leading innovation in Information Technology. As a CSV & Equipment Compliance Manager, you will be essential in ensuring regulatory compliance for Computer System Validation (CSV) activities. You will also deliver outstanding IT support and services. •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. Qualifications: •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. •Operational familiarity with data integrity principles and regulatory guidelines (FDA, EMA). •TIL Foundation, GxP compliance training, or certifications in relevant technologies (e.g., Windows Server, networking, or laboratory informatics systems). •This range represents the low and high end of the anticipated salary range for the California-based position. The actual base salary will depend on several factors such as experience, skills, and location. Compensation: •$97,000 - $146,000 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!