Senior Business Systems Validation Engineer

📋 Description

• Support validation and production activities for MES systems e.g. EBR and SAP, including system
• Support SAP and MES activities for new product introductions, including creation of new materials
• Maintain data integrity and data security risk assessments, including support for remediation of
• Support product lifecycle activities, including SOP updates, investigations, study plans
• Support the introduction of new products and new technologies, including equipment selection
• Provide validation guidance for automation and business systems changes, including suitability

🎯 Requirements

• Bachelor’s degree in Engineering, Science, or a related discipline preferred, or equivalent
• 5–10 years’ experience in MES/automation systems validation, new product introduction, and/or
• Experience with laboratory and manufacturing equipment validation, computer system validation, GAMP
• Knowledge of process performance qualification, cleaning validation, hold time studies, and
• Experience supporting ERP SAP systems and MES/EBR implementation.
• Familiarity with data historians such as OSI PI and reporting tools is an advantage.