CSV & Equipment Compliance Manager

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). Preferred Qualifications: Experience with some of the following production software systems: Unicorn, Factory Talk, Rockwell Systems, Empower, Chromeleon. TIL Foundation, GxP compliance training, or certifications in relevant technologies (e.g., Windows Server, networking, or laboratory informatics systems). Join Axolabs – Where Innovation Meets Impact in RNA Therapeutics At Axolabs, you’ll work in an international team driving groundbreaking progress in the development of nucleic acid–based medicines — from computational drug design and high‑throughput screening to large‑scale manufacturing. Our interdisciplinary teams bring together expertise in oligonucleotide chemistry, bioinformatics, molecular biology, process engineering, analytics and regulatory support. Whether you’re a scientist, technician, data expert or part of our operational teams — your work directly contributes to improving health outcomes for people around the world. With locations in Petaluma (USA), Kulmbach and Berlin (Germany), and as part of the LGC Group, we offer you a global, collaborative environment as both a CRO and CDMO. The typical pay range for this role is: Minimum: $97,000/Annual Maximum: $146,000/Annual 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. ABOUT LGC: LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high-quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality, and range.  OUR VALUES PASSION CURIOSITY  INTEGRITY BRILLIANCE RESPECT EQUAL OPPORTUNITIES  LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or maternity, religion, or belief. Short listing, interviewing and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership. This position requires current U.S. work authorization. We are unable to sponsor or assume sponsorship for temporary visas (including H‑1B, H‑2B, OPT, O‑1, TN) For more information about LGC, please visit our website  www.lgcgroup.com #scienceforasaferworld