Jr Computerized Systems Validation Specialist- Automation
- Workplace
- Hybrid
- Employment
- Full-time
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.
ABOUT THE ROLE
JC Automation is seeking a detail-oriented Junior CSV Specialist / Technical Writer to support validation documentation and computerized system qualification activities for a large pharmaceutical manufacturing project.
The selected candidate will assist experienced CSV professionals in preparing, reviewing, organizing, and maintaining technical documentation associated with pharmaceutical automation systems.
This opportunity is suitable for candidates with foundational knowledge of pharmaceutical validation, GMP documentation, and technical writing who are interested in developing their careers in automation and Computer System Validation.
RESPONSIBILITIES
Assist in preparing and maintaining CSV documentation, including validation plans, requirements specifications, test protocols, and traceability matrices.
Support technical documentation reviews for computerized manufacturing and automation systems.
Assist with the preparation and formatting of validation test scripts and qualification documents.
Maintain document revision histories, approval records, and validation tracking logs.
Support electronic documentation management and testing activities using Kneat or equivalent systems.
Review documentation for accuracy, completeness, consistency, and compliance with approved templates.
Assist with recording test discrepancies and tracking corrective actions.
Support the preparation of validation reports and system qualification packages.
Coordinate documentation activities with CSV Engineers, Area Leads, and Quality Assurance personnel.
Maintain organized validation records in accordance with GMP documentation practices.
Support validation documentation for DeltaV, PLC-based equipment, and other computerized manufacturing systems.
REQUIREMENTS & QUALIFICATIONS
Required
Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related discipline, or equivalent technical experience.
Recommended 0–3 years of relevant experience in CSV, pharmaceutical documentation, quality systems, or technical writing.
Basic understanding of GMP requirements and controlled documentation practices.
Strong technical writing, organizational, and attention-to-detail skills.
Proficiency in Microsoft Word, Excel, and document management applications.
Ability to work collaboratively within multidisciplinary engineering and validation teams.
Preferred
Previous exposure to pharmaceutical manufacturing or biotechnology environments.
Familiarity with GAMP 5, 21 CFR Part 11, and computerized system validation concepts.
Experience with Kneat, Veeva Vault, or electronic document management systems.
Basic knowledge of industrial automation systems such as Emerson DeltaV or Rockwell PLC.
Experience preparing technical procedures, specifications, or validation documentation.
Travel / On-Site Requirements: Periodic on-site attendance in Houston, depending on project requirements.
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