MES Validation Engineer

This is a remote position.

We are seeking an experienced MES Validation Engineer to support the deployment and validation of Manufacturing Execution Systems (MES) within a GMP-regulated biotechnology manufacturing environment. The successful candidate will be responsible for developing and executing validation strategies, protocols, and test scripts for computerized systems while ensuring compliance with FDA, EMA, GxP, and industry standards.

Key Responsibilities

• Develop, author, review, and execute validation protocols, test scripts, and validation reports for MES and computerized systems.
  
• Support implementation and validation of Rockwell FactoryTalk PharmaSuite and related manufacturing systems.
  
• Collaborate with IT/OT, Quality Assurance, Manufacturing, System Owners, and Business Process Owners to ensure validation activities align with GMP requirements.
  
• Develop validation strategies, risk assessments, traceability matrices, and testing plans.
  
• Execute Computer System Validation (CSV) activities including IQ, OQ, PQ, UAT, and system qualification.
  
• Ensure compliance with FDA, EMA, 21 CFR Part 11, GAMP 5, and Data Integrity requirements.
  
• Support change controls, deviations, CAPA investigations, and audit readiness activities.
  
• Manage testing execution, defect tracking, and validation deliverables throughout the project lifecycle.
  
• Work with regulated systems such as MES, LIMS, SCADA, ERP, and electronic records systems.
  
• Provide technical guidance on validation best practices and system compliance.
  

Required Qualifications

• Bachelor's degree in Biomedical Engineering, Computer Science, Biology, Biochemistry, Chemistry, Biotechnology, Regulatory Affairs, Information Technology, or related Life Sciences field.
  
• Minimum 5 years of experience in Computer System Validation (CSV) or Validation Engineering within a GMP-regulated environment.
  
• Experience with Rockwell FactoryTalk PharmaSuite.
  
• Strong knowledge of FDA, EMA, GxP, GAMP 5, and 21 CFR Part 11 requirements.
  
• Experience authoring and executing validation protocols and test scripts.
  
• Experience with risk assessments, change control, deviations, and CAPA processes.
  
• Strong verbal and written communication skills.
  
• Ability to work effectively in cross-functional teams.
  

Preferred Qualifications

• Experience with ValGenesis, LIMS, SCADA, ERP systems, DeltaV, or other regulated manufacturing platforms.
  
• Professional certifications such as CQE, CSQE, or CSVS.
  
• Experience supporting MES implementation projects.
  
• Knowledge of pharmaceutical, biotech, cell therapy, gene therapy, or biologics manufacturing operations.