Job DescriptionThis 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.
QualificationsMinimum 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).
Additional InformationThe 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.
