Data Integrity Risk Assessments and Validation Support
Job Description
Job Description
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
We are seeking a technically skilled and compliance-driven professional to support Data Integrity risk assessments and Computer System Validation (CSV) activities within a sterile and non-sterile pharmaceutical manufacturing environment. This role is critical to ensure that computerized and automated systems remain in a validated, compliant state throughout their lifecycle.
You will manage validation projects for laboratory, sterile, non-sterile, and utilities systems; execute and close CAPAs and investigations; lead the Computerized Systems Periodic Review Program; and support continuous improvement initiatives across the CSV lifecycle.
RESPONSIBILITIES
- Validation Management: Manage the validation of in-house projects for computer and automated systems across Laboratory, Sterile, Non-Sterile, and Utilities/Facilities Operations.
- CAPA & Investigation Execution: Manage, execute, and close CAPAs, Investigations, and other regulatory requirements, including Data Integrity Assessments for computerized systems.
- Periodic Review Program: Manage and execute the Computerized Systems Periodic Review Program, including periodic review of Data Integrity requirements for computerized systems.
- Continuous Improvement: Support initiatives associated with time reduction, paperless validation, and the implementation of corporate programs for computerized and automated systems.
- CSV Lifecycle Documentation: Support EBR and Laboratory Analytical Instruments upgrade initiatives, including development, routing, execution, and all related CSV Lifecycle documents.
- IT Compliance: Support CSV IT Compliance activities in alignment with site procedures and applicable regulatory standards (21 CFR Part 11, Data Integrity, ALCOA++).
REQUIREMENTS & QUALIFICATIONS
Required
- Bachelor's degree in Engineering (Electrical, Computer, Mechanical, Chemical), Life Sciences, or a related technical discipline.
- Minimum 3 years of experience in Computer System Validation (CSV) or Data Integrity assessment within a pharmaceutical or biotech GMP environment.
- Demonstrated experience authoring and executing CSV lifecycle deliverables — URS, FS, IQ, OQ, PQ, Traceability Matrix, Summary Reports.
- Working knowledge of FDA 21 CFR Part 11, ALCOA++ principles, and Data Integrity regulatory expectations.
- Experience managing CAPAs, investigations, and regulatory commitments in a pharmaceutical quality system.
- Bilingual in English and Spanish (oral and written).
Preferred
- Experience with GAMP 5 methodology and risk-based approaches to CSV.
- Familiarity with EBR systems and LIMS.
- Experience with Computerized Systems Periodic Review programs.
- Knowledge of cybersecurity requirements for GMP computerized systems.
SKILLS
Technical Skills
- CSV full lifecycle — URS, FS, IQ, OQ, PQ, Traceability Matrix, Summary Reports
- Data Integrity risk assessments and ALCOA++ compliance
- CAPA and investigation management in pharmaceutical quality systems
- Computerized Systems Periodic Review Program Execution
- 21 CFR Part 11 and GAMP 5 regulatory frameworks
- EBR systems and Laboratory Analytical Instruments validation
- Document Management Systems (DMS)
- Microsoft Office 365
Soft Skills
- Meticulous attention to detail in documentation and compliance activities
- Ability to manage multiple concurrent validation projects
- Clear communication with Quality, IT, and Engineering teams
- Proactive identification and escalation of compliance risks
- Strong organizational discipline in audit-ready documentation
- Accountability and follow-through on regulatory deliverables