Validation & Engineering Group, Inc. · 2 months ago
LL01-251112 Junior CSV Validation Specialist
Holly Springs, NC
Full-time
Onsite
Entry Level
2+ years expValidation & Engineering Group, Inc. is a leading services supplier providing solutions for various industries including Pharmaceutical and Biotechnology. They are seeking a Junior CSV Specialist to support the planning, execution, and documentation of Computer System Validation activities in compliance with GxP regulations and company policies.
BiotechnologyConsultingProfessional ServicesQuality Assurance
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
Qualification
Required
Bachelor's 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
Preferred
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
Company
Validation & Engineering Group, Inc.
Validation & Engineering Group, Proudly serving our clients since 1997.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2025-08-06Acquired
Leadership Team
Luis Puig
Partner
Recent News
News is my Business
2025-08-20
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