LIMS-ERP Integration Validation Specialist (Oracle)

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

Ensure that the bidirectional, API-based interface between the validated LabWare Laboratory Information Management System (LIMS) and the client’s Oracle ERP is incorporated into validation lifecycle documentation, requirements traceability, and qualification testing, so that information exchanged between both systems is accurate, complete, secure, and compliant with 21 CFR Part 11, GAMP 5, data integrity requirements, and client and JCA quality standards.The LIMS–ERP Integration Validation Specialist will work in a hybrid model supporting a client in the life sciences industry. Requirements, design review, test development, and coordination with Oracle integration resources may be performed remotely, while the execution of formal qualification testing must be performed onsite at the client facility in Rancho Cordova, California. The role is expected to be a part-time allocation, with higher demand during the Design phase and during interface qualification (currently forecast for Q3–Q4 2027). Occasional extended hours may be required during qualification execution and go-live activities. Candidates must be legally authorized to work in the United States.

RESPONSIBILITIES

• Review interface mappings, business rules, system-of-record definitions, and technical design information for the LIMS–Oracle interface.
• Develop interface requirements for the User Requirements Specification and interface content for the Application and Infrastructure System Design Specifications (e.g., message content, direction, triggers, error handling, security, and monitoring).
• Assess interface data risks, including critical data elements, data flows, and failure modes (lost, duplicate, or partial transactions, timeouts, and reconciliation), as input to the Data Risk Assessment and Data Integrity Assessment.
• Define the interface test strategy, including positive, negative, boundary, error-handling, retry, reconciliation, security, and audit trail scenarios, and coordinate test environments and Oracle test data with integration resources.
• Develop interface test scripts verifying bidirectional exchange of material master data, lot and manufacturing information, sample receipt, material disposition, and investigation status.
• Perform interface dry runs with Oracle integration and LabWare resources, and execute interface tests onsite, verifying data at source and target and capturing objective evidence (e.g., transaction records, logs, and screen captures).
• Document interface test discrepancies and support their resolution with integration developers, including retesting and closure.
• Ensure interface requirements are traced to design and test in the Requirements Traceability Matrix.
• Verify interface configuration as part of the Configuration Qualification in the Production environment, and support cutover and go-live monitoring.
• Provide input to the LIMS Administration Procedure on interface monitoring, error handling, and reprocessing.

• Comply with client and JCA Quality Management System (ISO 9001) requirements, including training, document control, and confidentiality obligations.

REQUIREMENTS & QUALIFICATIONS

Education

• Bachelor’s degree in Computer Science, Information Systems, Engineering, or a related scientific or technical field.
• An equivalent combination of education and directly related GMP computerized-system validation or integration experience may be considered.

Experience

• Minimum of five (5) years of experience in Computer System Validation or regulated IT in the pharmaceutical, biotechnology, or other GMP-regulated industry.
• Minimum of three (3) years of experience validating or implementing system interfaces (e.g., LIMS–ERP, MES–ERP, LIMS–MES, or LIMS–CDS).
• Experience developing and executing interface or integration test scripts.
• Experience with data migration verification or data reconciliation between systems.

Preferred

• Experience with LIMS–Oracle (e.g., Oracle E-Business Suite or Oracle Cloud) or LIMS–SAP QM integrations.
• Experience with LabWare LIMS interfaces or web services.
• Experience with integrations involving quality management systems (e.g., investigation status).
• Experience applying Computer Software Assurance (CSA) principles to interface testing.
• ISPE GAMP training or equivalent is a plus.

SKILLS

Technical Skills

• Understanding of system integration concepts, including APIs and web services (REST/SOAP), data formats (JSON/XML), middleware, message queues, and error handling.
• Understanding of ERP material and quality processes, including material master, lot management, sample receipt, and material disposition.
• Ability to verify data between systems using SQL queries, reports, and field-level comparisons.
• Working knowledge of 21 CFR Part 11, GAMP 5, and data integrity requirements (ALCOA+) as they apply to interfaced data.
• Ability to design interface test cases and write clear test steps with objective acceptance criteria.
• Familiarity with API testing and log analysis tools (e.g., Postman, SoapUI).
• Proficiency in Microsoft Office applications (Word, Excel, and Visio).
• Excellent oral and written communication skills in English; Spanish is a plus.
• Collaborative and able to coordinate effectively with IT, integration, and Quality personnel.

Soft Skills

• 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