Computer Validation Specialist

Industry: Pharmaceutical / Life Sciences

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.

• At least 3 years of specialized experience in the Pharmaceutical Industry as a CSV specialist.
• Strong background in applying the V-Model validation framework within Agile or Waterfall methodologies.

• 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.
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