Validation Engineer - Casa Grande, AZ
Core
Ensure change control and validation activities are executed timely in compliance with Abbott Nutrition policies, standards, and regulatory requirements (cGMP, GDP) for a nutrition manufacturing plant.
Role type
Validation Engineer (Manufacturing)
Builds
Validated equipment, systems, utilities, and processes for nutrition product manufacturing
Domain
Healthcare / Nutrition Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Design Control, Good Documentation Practices (GDP), current Good Manufacturing Practices (cGMP), protocol writing and execution, change control management, impact assessment, deviation investigation, data collection and verification, audit support
Preferred skills
GAMP5 familiarity, FDA Computer Software Assurance initiatives knowledge, mentorship, independent project execution, network cultivation
Technologies
Microsoft Word, Excel, Outlook
Responsibilities
Review, guide, and develop Design Qualification processes (SIA, PVP, FMEA, URS); execute validation protocols (IQ, OQ, PQ, CSV); support change control activities; compile and maintain validation documentation; assist in investigation and resolution of validation deviations; collaborate with Engineering, Quality, Operations, and IT teams; support internal and external audits and inspections
Seniority
Mid-level, hands-on IC
