Computer System Validation (CSV) C&Q Technical Lead-Automation in Carolina at JC Automation Corp
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:
The Computer System Validation (CSV) C&Q Technical Lead for Automation plays a critical role in ensuring that automated systems within the manufacturing environment meet all regulatory and quality standards. This position is responsible for leading the validation and commissioning/qualification (C&Q) activities of computer systems, ensuring compliance with industry regulations such as FDA 21 CFR Part 11 and GxP guidelines. The role involves collaborating closely with cross-functional teams including Quality Assurance, IT, and Engineering to develop and execute validation protocols, risk assessments, and documentation. The Technical Lead will also provide expert guidance on automation system design, implementation, and maintenance to support continuous improvement and operational excellence. Ultimately, this position ensures that all automated systems are validated to guarantee product quality, patient safety, and regulatory compliance throughout the product lifecycle.
Responsibilities:
- Partner with process engineering to ensure automation requirements are aligned with business needs.
- Manage technical changes and provide technical direction through all software development and testing activities.
- Partner with the Design Verification Lead to ensure alignment between CSV and verification expectations.
- Provide direction for CSV strategy, validation approach, and major CSV deliverables (Requirements, Design, Security Plan, Test Plan, etc.).
- Lead development and execution of Commissioning and Qualification (C&Q) protocols (IQ/OQ/PQ) for automation and control systems.
- Develop all related CSV documentation (validation plans, requirements traceability matrices, test scripts, summary reports) ensuring it complies with GAMP 5 and applicable specifications and company quality system procedures.
- Coordinate CSV activities with Quality Assurance, Automation Engineering, and Commissioning teams to support project schedule and data integrity requirements.
- Manage deviations, discrepancies, and change controls associated with C&Q and CSV activities.
- Develop and maintain CSV training materials and matrices for the CSV team, automation integrator, CSV service provider, and Client USER groups.
- Support FAT/SAT execution and assist with system handover to the Client USER team.
- Provide CSV input to the C&Q schedule and progress reporting, including system definition/classification and baseline CSV milestones.
Key Qualifications:
- Bachelor's degree in Automation, Controls, Chemical/Electrical Engineering, Computer Science or a related field or an equivalent combination of education and relevant experience.
- Demonstrated experience providing technical direction on automation system architecture, hardware/software platforms, and programming standards within a pharmaceutical, biotech, or comparable regulated capital-project environment.
- Experience reviewing control system and packaged equipment vendor documentation and supporting automation hardware, software and licensing procurement.
- Working knowledge of data historians, batch reporting systems, and manufacturing execution systems (MES).
- Experience performing functional P&ID reviews, leading prototyping activities, and managing technical/engineering changes.
- Strong understanding of Computer System Validation (CSV) principles, GAMP 5 methodology, and data integrity (ALCOA+) requirements.
- Experience developing and executing C&Q protocols (IQ/OQ/PQ) and major CSV deliverables, including validation plans, requirements traceability matrices, test scripts, and summary reports.
- Ability to partner effectively with Design Verification, Process Engineering, Quality Assurance, and Commissioning teams.
- Strong organizational, communication, and leadership skills to drive technical direction across multi-disciplinary teams under a dynamic project schedule.
Desired Qualifications:
- Prior experience as an Automation Lead or CSV/C&Q Technical Lead on a large-scale pharmaceutical or biotech capital project.
- Experience with alarm management strategy and manufacturing execution system (MES) implementation.
- Experience supporting regulatory inspections and audits related to automation and computer system validation.
Soft Skills:
- Adaptability: working effectively under a dynamic project schedule
- Leadership: providing technical direction across multi-disciplinary teams
- Organization and attention to detail
- Communication: clearly conveying CSV strategy expectations and progress to stakeholders and clients
Scan to Apply
Just scan this QR code to apply from your phone.
- Fast
- Easy
- Apply on the go
