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LL01-250919 Manufacturing Execution Systems Validation Specialist (NC)
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 :
Senior Computer System Validation (CSV) Specialist
Manufacturing Execution Systems (MES), specifically Syncade , to support a biologics manufacturing facility. The role will be responsible for planning, authoring, executing, and reviewing validation deliverables in compliance with FDA, EMA, ICH, and GAMP 5 guidelines. The candidate will work closely with Quality, IT, Engineering, and Manufacturing teams to ensure validated, compliant, and reliable MES system operation throughout the system life cycle.
Key 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.Qualifications
Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field. Advanced degree preferred.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 Skills
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.J-18808-Ljbffr
