LL01-250919 Senior Computer System Validation (CSV) Specialist jobs in United States
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Validation & Engineering Group, Inc. · 3 months ago

LL01-250919 Senior Computer System Validation (CSV) Specialist

positionMorrisville, NC
timeFull-time
remoteOnsite
senioritySenior Level
date7+ years exp

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. They are seeking a Senior Computer System Validation (CSV) Specialist with expertise in Manufacturing Execution Systems (MES) to support a biologics manufacturing facility, ensuring compliance with regulatory guidelines and leading validation activities.

BiotechnologyConsultingProfessional ServicesQuality Assurance

Responsibilities

Lead and execute CSV activities for MES (Syncade) in a biologics GMP environment
Develop and maintain validation documentation including Validation Plans, User Requirements (URS), Functional Specifications (FS), Design Specifications (DS), Risk Assessments, IQ/OQ/PQ protocols, and summary reports
Partner with Manufacturing and Quality to ensure MES recipes, workflows, and master batch records are validated and compliant
Perform impact assessments and change control for system upgrades, patches, and enhancements
Ensure alignment of CSV deliverables with GAMP 5, 21 CFR Part 11, Annex 11, and other applicable regulations
Collaborate with IT and Engineering teams for system integration (e.g., LIMS, ERP/SAP, DeltaV, PI Historian)
Provide audit support during regulatory inspections (FDA, EMA, MHRA, etc.) and customer audits
Mentor junior validation engineers and support knowledge transfer on CSV best practices
Contribute to continuous improvement of MES validation strategies, procedures, and templates

Qualification

Computer System ValidationManufacturing Execution SystemsMES SyncadeRegulatory guidelines knowledgeBiologics manufacturing processesTechnical writing skillsLeadership abilitiesProblem-solving abilitiesCommunication skills

Required

Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field
7–10+ years of experience in Computer System Validation within GMP-regulated biologics/pharmaceutical manufacturing
Hands-on expertise with MES Syncade validation and configuration (recipes, workflows, batch records)
Strong knowledge of regulatory guidelines: FDA 21 CFR Part 11, EU Annex 11, ICH Q7, GAMP 5
Experience in biologics manufacturing processes (cell culture, purification, fill/finish)
Familiarity with integration points (DCS/DeltaV, LIMS, ERP/SAP, data historians)
Excellent technical writing and documentation skills
Strong communication, leadership, and problem-solving abilities

Preferred

Experience in large-scale biotech/biologics start-up or tech transfer projects
Knowledge of data integrity principles and ALCOA+ requirements
Exposure to quality management systems (TrackWise, Veeva, ValGenesis, Kneat)
Understanding of 21st Century Cures Act and CSA (Computer Software Assurance) approaches

Company

Validation & Engineering Group, Inc.

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Validation & Engineering Group, Proudly serving our clients since 1997.
dateFounded in 1997
location
Guaynabo, NA - Puerto Rico, PRI
people-size51-200 employees
web-link
http://veg-group.com/

Funding

Current Stage
Growth Stage
Total Funding
unknown
2025-08-06Acquired

Leadership Team

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Luis Puig
Partner
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Recent News

News is my Business
Pinnaql buys Validation & Engineering Group to boost life sciences reach
2025-08-20
PR Newswire
Pinnaql Acquires VEG, Broadening Manufacturing Compliance & Quality Services Platform
2025-08-06
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