Senior Business Systems Validation Engineer
AbbVie · Cork, Ireland
QualityFull timeCompany career page
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Role summary
AbbVie seeks a Senior Business Systems Validation Engineer to support manufacturing business systems validation, particularly MES and SAP implementations in a pharmaceutical environment. The role encompasses system upgrades, new product introductions, GMP compliance, and cross-functional validation activities throughout the product lifecycle.
What they're looking for
- Bachelor's degree in Engineering, Science, or related discipline; or equivalent relevant experience
- 5–10 years' experience in MES/automation systems validation and manufacturing support in GMP-regulated environment
- Laboratory and manufacturing equipment validation expertise; knowledge of GAMP 5 and EU Annex 15
- Experience with ERP SAP systems and MES/EBR implementation
- Process performance qualification, cleaning validation, and validation lifecycle knowledge
- Strong project management, problem-solving, and communication abilities
- Data historians (OSI PI) or reporting tools experience is advantageous
What you'll be doing
- Support validation and production activities for MES systems including upgrades, issue resolution, and continuous improvement
- Lead validation activities for new product introductions including materials, BOMs, recipes, and system validation
- Maintain data integrity and security risk assessments; support legacy system remediation
- Write and execute validation protocols for cleaning, equipment, utilities, facilities, and automation systems
- Support change control activities, validation documentation review, audit readiness, and cross-functional projects
Privacy & handoff
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