Senior Business Systems Validation Engineer
Core
Lead validation and technical support for manufacturing business systems (MES, SAP, POMSnet) to ensure GMP compliance and support new product introductions within the pharmaceutical manufacturing environment.
Role type
Senior Business Systems Validation Engineer
Builds
Validated manufacturing systems (MES, SAP, POMSnet) and supports new product introductions
Domain
Pharmaceutical manufacturing / Computer System Validation (CSV)
Required skills
Computer System Validation (CSV), GAMP 5, EU Annex 15, MES/automation systems validation, SAP/ERP support, data integrity management, change control, audit readiness, process performance qualification, cleaning validation, project management
Preferred skills
Data historians (OSI PI), reporting tools, AI tools adoption
Technologies
SAP, POMSnet, EBR, OSI PI
Responsibilities
Execute validation protocols for equipment, utilities, facilities, and processes; support new product introductions including BOMs and recipes; maintain data integrity and security risk assessments; support GMP, FDA, and supplier audits; lead cross-functional project groups for system changes.
Seniority
Senior, hands-on IC
