Computer Systems Validation (CSV) Engineer- Automation
Theron Partners Inc.
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Job Details
Skills
- Pharmaceutics
- GMP
- GAMP
- V-Model
- Regulatory Compliance
- Auditing
- Software Development Methodology
- Programmable Logic Controller
- HMI
- Manufacturing
- Computerized System Validation
- Management
- ServiceNow
- IT Service Management
- GxP
- Data Integrity
- Data Governance
- SANS
Summary
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
- Dice Id: 91173088
- Position Id: OOJ - 1064-68-1776870424
- Posted 1 day ago
Company Info
About Theron Partners Inc.
Theron Partners Inc. is a founder-led, boutique staffing and technology services firm focused on delivering high-quality talent and tailored solutions to US enterprises.
Built by industry professionals with deep experience in the US staffing and consulting landscape, we operate with a hands-on leadership approach—ensuring every engagement meets the highest standards of quality, responsiveness, and accountability.
We specialize in technolgy staffing, professional services, consulting, and project delivery, providing access to a carefully curated network of proven tech professionals across critical and next-generation solutions. Our vendor-independent model allows us to remain fully objective, aligning technology and talent decisions strictly with our clients’ business goals.
As a boutique firm, we value relationships over transactions, precision over volume, and long-term success over short-term wins. We partner closely with our clients as an extension of their teams—delivering dependable results, scalable solutions, and enduring value.
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