CSV & Equipment Compliance Manager

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.

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.

Job Purpose

• 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.

Key Responsibilities

• Ensure regulatory adherence of CSV activities in accordance with applicable guidelines and regulations.
• Deliver IT assistance and services for desktops and instrument workstations functioning in GMP-regulated environments or aiding production processes in a manufacturing setting.
• Act as primary liaison with third-party equipment vendors for procurement, installation, qualification, and maintenance activities.
• Serve as the interface between business teams and Corporate IT, encouraging effective communication and alignment.

Minimum 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).

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

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