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Junior CSV Validation Specialist

3 weeks ago

Holly Springs, NC, United States Validation & Engineering Group Inc. Full time
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:
  • Junior CSV Specialist
The Junior CSV Specialist supports the planning, execution, and documentation of Computer System Validation (CSV) activities in compliance with GxP regulations and company policies. The role assists in ensuring that computerized systems used in GMP-regulated environments are validated, maintained in a compliant state, and operate reliably to support manufacturing, laboratory, and quality operations.

Key Responsibilities
  • Assist in preparing and executing validation deliverables including User Requirements (URS), Functional Specifications (FS), Design Specifications (DS), Risk Assessments, Validation Plans, and Reports.
  • Support the creation and execution of IQ/OQ/PQ protocols for GMP systems (e.g., LIMS, MES, SCADA, PLCs, ERP, QMS, Data Historian, etc.).
  • Maintain validation documentation in accordance with GAMP 5, 21 CFR Part 11, Annex 11, and company SOPs.
  • Participate in system change control, deviation management, and periodic review processes.
  • Collaborate with IT, QA, and system owners to ensure compliance throughout the system lifecycle.
  • Assist in performing data integrity assessments and periodic audits of validated systems.
  • Track and maintain validation status of systems and associated documentation.
  • Support the implementation and qualification of new systems or upgrades under supervision of senior validation staff.
Qualifications
  • Education: Bachelor's degree in Engineering, Computer Science, Life Sciences, or related technical field.
  • Experience:
    • 2-4 years of experience in Computer System Validation or related GxP compliance field.
    • Familiarity with GAMP 5, 21 CFR Part 11, and GMP principles preferred.
    • Internship or exposure to validation in a biotech, pharmaceutical, or medical device setting is a plus.
  • Technical Skills:
    • Basic understanding of system development lifecycle (SDLC).
    • Proficiency in Microsoft Office, especially Word and Excel.
    • Exposure to systems such as LIMS, QMS, or automation platforms (PLC/SCADA) desirable.
  • Soft Skills:
    • Strong attention to detail, documentation, and analytical thinking.
    • Ability to follow procedures, work collaboratively, and meet deadlines.
    • Effective written and verbal communication skills.