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FTSi.Tech • Greenville, North Carolina, United States
Role & seniority: Computer Validation Specialist (Validation Analyst or CQV/CSV Engineer), Full-Time, onsite
Stack/tools: IQ/OQ/PQ protocols; industrial ladder logic, Visual Basic; SCADA (Allen-Bradley Rockwell), PLCs, DCS; electronic document management (Documentum); Trackwise; SOP development aligned with FDA
Develop and execute IQ/OQ/PQ protocols and compile Validation Summary Reports (VSR)
Author/assess core validation deliverables (VMP, URS, FRS) and ensure regulatory alignment
Apply risk-based validation across applications/infrastructure; oversee sitewide sterile manufacturing change management and data integrity
3–5 years in Validation (GxP) as Analyst/CQV/CSV
Experience with IQ/OQ/PQ and FDA-equivalent SOPs
Ability to read/interpret ladder logic or Visual Basic; familiarity with SCADA/PLCs/DCS and document management systems
3+ years pharma CSV experience
Experience applying V-Model within Agile or Waterfall environments
Location & work type: Onsite, Greenville, NC; full-time, onsite manufacturing environment
Title: Computer Validation Specialist
Employment Type: Full-Time
Industry: Pharmaceutical / Life Sciences
Location: Onsite - Greenville, NC
Role Description: We are seeking a highly skilled Validation Analyst or CQV/CSV Engineer to support sterile manufacturing lines and site-wide change management. The successful candidate will be responsible for the full validation lifecycle within GxP environments, bridging the gap between industrial automation and regulatory compliance. You will utilize a risk-based approach to validate both configured and custom-developed systems, ensuring all software and infrastructure meet stringent federal requirements.
Experience: 3–5 years of experience as a Validation Analyst, CQV Engineer, or CSV Engineer in GxP environments.
Compliance Knowledge: Extensive experience with IQ, OQ, and PQ (Installation, Operational, and Performance Qualification) protocols.
Technical Skills: Ability to read and interpret computer code, specifically industrial ladder logic, Visual Basic, or similar modular code structures.
Systems Familiarity: Proven experience validating SCADA systems (Allen Bradley Rockwell), manufacturing PLCs, Distributed Control Systems (DCS), Electronic Document Management Systems (e.g., Documentum), and Trackwise.
Regulatory: Thorough experience writing, reviewing, and revising Standard Operating Procedures (SOPs) to ensure alignment with FDA regulations.
Location: Must be able to work onsite in Greenville, NC.
Protocol Development: Develop and execute IQ, OQ, and PQ protocols; prepare comprehensive Validation Summary Reports (VSR) to consolidate all documentation and activities.
Deliverable Management: Author and assess core validation deliverables, including Validation Master Plans (VMP), User Requirement Specifications (URS), and Functional Requirement Specifications (FRS).
Risk Management: Implement a Risk-Based approach to validate a wide variety of applications and infrastructure.
Site Support: Support the Steriles Manufacturing lines change management process for the entire site, ensuring continuous compliance.
Systems Oversight: Oversee the validation of complex manufacturing and document management systems to ensure data integrity and operational reliability.
FTSi.Tech Disclosure: FTSi.Tech serves as a staffing agency, not the end client for this position. Our mission is to connect candidates with superior career opportunities while delivering exceptional talent to our clients. We are committed to facilitating successful and mutually beneficial placements for both candidates and clients. Your Success Is Our Focus!