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MES Engineer

Validation & Engineering Group -
Morrisville, NC

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Job Details

Full-time

Qualifications

Systems integration
Cell line culture
GAMP
Content creation for technical audiences
Technical documentation
Pharmaceutical regulatory compliance
SAP
ICH Q7
Technical writing experience within manufacturing
FDA 21 CFR Part 11
Manufacturing facility experience
Production validation processes
Pharmaceutical company experience
Batch records
ICH Q10
Bioprocessing
Project leadership
Pharmaceutical manufacturing facility experience

Full Job Description

Company Description

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.

Job Description

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.

Additional Information

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

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MES Engineer

Lead Process Engineer

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