What are the responsibilities and job description for the Computer Systems Validation (CSV) Engineer- Automation position at Theron Partners Inc.?
Job Title: Computer Systems Validation (CSV) Engineer - Automation
Location: Lebanon, IN
Duration: 12 Months Contract
Schedule: Onsite Role (All 5-Days)
Job Description:
Required Skills:
- Demonstrated experience in computer systems validation (CSV) for automation and control systems in a pharmaceutical/GMP-regulated environment.
- Strong knowledge of GAMP 5 methodology, V-model lifecycle, and risk-based validation approaches.
- Experience with 21 CFR Part 11 compliance, including assessment of electronic records, electronic signatures, and audit trail requirements.
- Proficiency in developing validation deliverables across SDLC Life cycle.
- Experience with DCS, PLC/HMI, and/or historian systems in a manufacturing environment.
- Strong understanding of FDA and EMA regulatory expectations for computerized system validation.
- Direct experience validating DeltaV, PI Historian, Rockwell FactoryTalk, or Metasys platforms.
- Experience with ServiceNow platform validation or ITSM system validation in a GxP context.
- Familiarity with data integrity principles (ALCOA ) and data governance frameworks.
- Experience with Kneat, ValGenesis, or similar electronic validation
- 7-10 Years Experience