CSV & Equipment Compliance Manager

LGC Group•Petaluma, CA

4h•$97,000 - $146,000•Onsite

About The Position

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.

Requirements

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).
Current U.S. work authorization.

Nice To Haves

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).

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.
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.