MES Engineer

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.   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 - 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. All your information will be kept confidential according to EEO guidelines.