LIMS Validation and CSV Qualification Specialist

LIMS Validation and CSV Qualification Specialist

Contractor - 3rd Party PR, PR

About Company:

JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.

JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.

ABOUT THE ROLE

Plan, develop, coordinate, and execute the validation lifecycle and qualification activities required to expand a validated LabWare Laboratory Information Management System (LIMS) supporting GMP Quality Control laboratory operations. Ensure that new LIMS functionality, including Stability Management, Reagent and Standard Inventory, user roles and security, and applicable system interfaces, is delivered in a validated and inspection‑ready state in accordance with 21 CFR Part 11, 21 CFR Parts 210 and 211, GAMP 5, data integrity requirements, and client and JCA quality standards.The LIMS Validation and CSV Qualification Specialist will work in a hybrid model supporting a client in the life sciences industry. Documentation development, review, and test preparation may be performed remotely, while formal qualification execution must be performed onsite at the client facility in Rancho Cordova, California. The role operates within a GMP-regulated Quality Control laboratory and computerized‑systems environment and requires coordination with client Quality, Laboratory, IT, and vendor personnel. Allocation is expected to increase during qualification and go‑live phases. Occasional extended hours may be required during execution windows. Candidates must be legally authorized to work in the United States.

RESPONSIBILITIES

• Participate in project, validation, design, testing, and readiness meetings, providing validation input throughout the project lifecycle.
• Review approved requirements, business rules, system design, and configuration information to define validation strategy, qualification scope, and test coverage.
• Develop and revise validation lifecycle documentation, including the Validation Master Plan, User Requirements Specification, Application System Design Specification, Infrastructure System Design Specification, Data Risk Assessment, and Data Integrity Assessment.
• Apply risk‑based validation and Computer Software Assurance principles so that testing and documentation are proportionate to system criticality, intended use, and GxP impact.
• Develop and maintain the Requirements Traceability Matrix, linking approved requirements to design, configuration, qualification testing, and execution results.
• Develop Functional Qualification and Configuration Qualification protocols and reproducible test scripts with objective acceptance criteria.
• Develop test coverage for Stability Management, Reagent and Standard Inventory, user roles and security, audit trails, electronic records and signatures, reporting, and applicable LIMS–Oracle interface functionality.
• Define test prerequisites, test data, test accounts, and environment‑readiness requirements in coordination with configuration, integration, and client resources.
• Perform protocol dry runs in the Development environment and incorporate required corrections before protocol approval.
• Execute approved qualification protocols onsite in the Validation and Production environments and capture objective evidence in accordance with Good Documentation Practices and ALCOA+ principles.
• Document, assess, and support resolution of test discrepancies, exceptions, and deviations, including impact evaluation, retesting, and closure.
• Update traceability and report qualification status and test metrics, including scripts executed, passed, failed, and open discrepancies.
• Support document review and approval cycles with the System Owner, Quality Assurance, and Quality Technical Services.
• Support validation readiness, go‑live, production release, approved changes to existing functionality, and preparation of the Validation Summary Report.
• Provide knowledge transfer to client personnel on validation deliverables, procedures, and qualified LIMS functionality, as required.
• Comply with client and JCA Quality Management System requirements, including training, document control, and confidentiality obligations.

REQUIREMENTS & QUALIFICATIONS

Education

• Bachelor’s degree in C