Senior Computer System Validation (CSV) Specialist

Senior Computer System Validation (CSV) Specialist

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, 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

Preferred Skills