LL01-251112 Junior CSV Validation Specialist

Validation & Engineering Group • Holly Springs, NC

39d

About The Position

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.

Requirements

• Bachelors degree in Engineering, Computer Science, Life Sciences, or related technical field.
• 2-4 years of experience in Computer System Validation or related GxP compliance field.
• Basic understanding of system development lifecycle (SDLC).
• Proficiency in Microsoft Office, especially Word and Excel.
• Strong attention to detail, documentation, and analytical thinking.
• Ability to follow procedures, work collaboratively, and meet deadlines.
• Effective written and verbal communication skills.

Nice To Haves

• 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.
• Exposure to systems such as LIMS, QMS, or automation platforms (PLC/SCADA) desirable.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Personal and Laundry Services
• Number of Employees: 101-250 employees