About this role
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.
Position Summary
JC Automation is seeking a qualified CSV Engineer / Specialist to support Computer System Validation activities for pharmaceutical manufacturing automation systems.
The selected candidate will be responsible for developing validation documentation, reviewing technical specifications, supporting testing activities, and ensuring computerized systems comply with applicable GMP and regulatory requirements.
The position involves collaboration with Automation Engineering, Quality Assurance, and project execution teams.
Key Responsibilities
Develop and maintain Computer System Validation documentation throughout the system lifecycle.
Prepare and review requirements specifications, functional specifications, risk assessments, and traceability matrices.
Develop and execute validation test protocols for computerized manufacturing systems.
Review automation system documentation to ensure alignment with validation requirements.
Support validation of Emerson DeltaV, Rockwell PLC, and vendor package equipment.
Document test results, collect objective evidence, and maintain accurate electronic validation records.
Identify, document, and support resolution of test discrepancies and validation deviations.
Participate in change control and validation impact assessments.
Support verification of system access controls, audit trails, electronic records, and data integrity requirements.
Coordinate with Automation Engineers, System Integrators, and Quality Assurance personnel.
Support preparation of validation summary reports and system qualification packages.
Maintain validation documentation within Kneat or other approved electronic systems.
Required Qualifications
- 5 years Computer System Validation experience (or equivalent experience)
- 5 years working in Biopharma engineering, operations, or manufacturing
- Preferred Kneat Experience (Power User), Veeva Vault
- Exceptional teamwork ability
- Deep Knowledge of GMP, regulatory requirements, and computer system validation
- Excellent written and verbal communication skills for both technical and non-technical audiences.
Preferred Qualifications
Experience with Kneat or Veeva Vault.
Knowledge of FactoryTalk AssetCentre, AVEVA PI, or other industrial automation applications.
Experience supporting pharmaceutical capital projects.
Familiarity with commissioning, qualification, and system integration activities.
Travel / On-Site Requirements: Regular on-site presence in Houston is preferred, with attendance based on project needs.
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