Validation Engineering Group, Inc. logoValidation Engineering Group, Inc. logo

Senior MES Engineer - Computer System Validation Specialist

On-site Full-time

Clicking Apply Now takes you to AutoApply where you can tailor your resume and apply.


Experience Level

Mid to Senior

Qualifications

Qualifications:Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related field. An advanced degree is preferred.7–10+ years of experience in Computer System Validation within GMP-regulated biologics or pharmaceutical manufacturing. Hands-on experience with MES Syncade validation and configuration, including recipes, workflows, and batch records. In-depth understanding of regulatory guidelines: FDA 21 CFR Part 11, EU Annex 11, ICH Q7, GAMP 5.Familiarity with biologics manufacturing processes such as cell culture, purification, and fill/finish. Knowledge of system integration points (DCS/DeltaV, LIMS, ERP/SAP, data historians). Exceptional technical writing and documentation capabilities. Strong communication, leadership, and problem-solving skills. Preferred Skills:Experience in large-scale biotech or biologics start-up or technology transfer projects. Familiarity with data integrity principles and practices.

About the job

Join our team as a Senior Computer System Validation (CSV) Specialist! We are seeking a talented MES Engineer with extensive experience in Manufacturing Execution Systems (MES), specifically Syncade, to enhance our biologics manufacturing facility. In this role, you will be pivotal in the planning, authoring, executing, and reviewing of validation deliverables while adhering to FDA, EMA, ICH, and GAMP 5 guidelines. You will collaborate closely with Quality, IT, Engineering, and Manufacturing teams to ensure the MES system operates in a validated, compliant, and reliable manner throughout its lifecycle.

Key Responsibilities:

  • Lead and execute CSV initiatives for MES (Syncade) in a GMP environment focused on biologics.
  • Develop and maintain comprehensive validation documentation, including Validation Plans, User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), Risk Assessments, and IQ/OQ/PQ protocols.
  • Collaborate with Manufacturing and Quality teams to validate MES recipes, workflows, and master batch records.
  • Conduct impact assessments and manage change controls for system upgrades, patches, and enhancements.
  • Ensure compliance of CSV deliverables with GAMP 5, 21 CFR Part 11, Annex 11, and other relevant regulations.
  • Work alongside IT and Engineering teams for effective system integrations (e.g., LIMS, ERP/SAP, DeltaV, PI Historian).
  • Provide support during regulatory audits (FDA, EMA, MHRA, etc.) and customer inspections.
  • Mentor junior validation engineers and facilitate knowledge sharing on CSV best practices.
  • Contribute to the continuous improvement of MES validation strategies, procedures, and templates.

About Validation Engineering Group, Inc.

Validation & Engineering Group, Inc. (V&EG) stands as a premier service provider offering tailored solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices sectors. Our expertise spans Laboratory, Compliance, Computer Engineering, Project Management, Validation, and beyond, ensuring our clients receive the highest quality of service.

Similar jobs

Browse all companies, explore by city & role, or SEO search pages.

Tailoring 0 resumes

We'll move completed jobs to Ready to Apply automatically.