LLSenior Computer System Validation; CSV Specialist; NC

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 - with expertise in 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, Delta
  
  V, 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/Delta
  
  V, 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 (Track Wise, Veeva, Val Genesis, Kneat).
• Understanding of 21st Century Cures Act and CSA (Computer Software Assurance) approaches.