LIMS Validation and CSV Qualification Specialist

JC Automation Corp• US, PR

13h•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, Information Systems, Communications, or a related scientific or technical field.
An equivalent combination of education and directly related GMP laboratory systems experience may be considered.
Minimum of five (5) years of Computer System Validation experience in the pharmaceutical, biotechnology, or other GMP-regulated industry.
Minimum of three (3) years of hands-on experience with an enterprise LIMS (validation, implementation, configuration, or administration) in a GMP Quality Control laboratory environment.
Proven experience developing and executing qualification protocols and test scripts (IQ/OQ/PQ, FQ/CQ, or equivalent), including dry runs, test discrepancy management, and retesting.
Experience authoring validation lifecycle deliverables, such as Validation Plans, User Requirements, Design Specifications, Risk Assessments, Traceability Matrices, and Validation Summary Reports.
Experience developing or revising GMP procedures (SOPs) for computerized systems.
Experience working within change control and deviation management processes.
Working knowledge of 21 CFR Part 11, 21 CFR Parts 210 and 211, GAMP 5, and data integrity requirements (ALCOA+), including electronic records and electronic signatures.
Strong understanding of Computer System Validation (CSV) and Computer Software Assurance (CSA) principles, risk-based validation, and the validation lifecycle.
Knowledge of LIMS concepts, including master data, specifications, sample lifecycle, user roles and security, audit trails, reporting, and system interfaces.
Understanding of QC laboratory processes, including stability programs, reagent and standard management, sample testing, OOS/OOT investigations, and material disposition.
Ability to translate business workflows and SME input into clear requirements, test scripts, and operational procedures.
Excellent technical writing skills with the ability to produce clear, accurate, and inspection-ready validation deliverables and SOPs.
Proficiency in Microsoft Office applications (Word, Excel, PowerPoint, and Visio) and familiarity with electronic validation or test management tools (e.g., Kneat, HP ALM, ValGenesis).
Strong attention to detail, organizational skills, and ability to manage multiple deliverables to schedule.
Excellent oral and written communication skills in English; Spanish is a plus.
Collaborative, client-focused, and able to work independently with minimal supervision in cross-functional teams.
Strong attention to detail and commitment to documentation accuracy
Clear and proactive communication across multidisciplinary teams
Ability to work independently in a structured field environment
Organized, methodical, and adaptable under project timelines
Team-oriented with a collaborative approach to problem solving
Willingness to work on-site during testing, startup, and qualification phases

Nice To Haves

LabWare LIMS experience is preferred; experience with other enterprise LIMS platforms (e.g., Thermo Scientific SampleManager, STARLIMS, LabVantage) is considered equivalent when it covers comparable functionality (master data, specifications, stability, security, and interfaces) and the candidate demonstrates the ability to quickly apply that knowledge to LabWare LIMS.
Direct hands-on LabWare LIMS experience (configuration, administration, or validation), including LabWare validation on implementation, expansion, or upgrade projects.
Experience validating or administering LIMS Stability Management functionality (study planning, pull scheduling, chamber management, stability evaluation, and trending).
Experience with LIMS Reagent and Standard Inventory functionality (receipt, preparation, standard qualification, expiration management, and usage traceability).
Experience validating LIMS–ERP integrations (e.g., Oracle, SAP QM), including API-based interfaces.
Experience performing Data Risk Assessments and Data Integrity Assessments.
LIMS administration experience, including user access management, audit trail review, and periodic user access reviews.
Experience with LIMS data migration verification, system upgrades, or laboratory instrument/CDS integrations (e.g., Empower, SDMS).
Professional certification such as ISPE GAMP training, ASQ CQA/CSQE, or equivalent is a plus.

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.