Validation Engineer
Core
Execute lifecycle qualification of manufacturing equipment, utilities, and facilities to ensure compliance with GMP and regulatory standards.
Role type
Senior Validation Engineer (Pharmaceutical Manufacturing)
Builds
Qualified equipment, utility systems, and manufacturing areas for pharmaceutical production
Domain
Pharmaceutical manufacturing / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Lifecycle qualification execution (URS review, DQ, FAT, SAT, IQ, OQ, PQ), GMP documentation, deviation/CAPA investigation support, regulatory inspection coordination, SOP development, project engineering participation
Preferred skills
Experience with HVAC, compressed air, and purified water systems
Technologies
Microsoft Office (Word, Excel, Access, PowerPoint)
Responsibilities
Execute qualification activities throughout equipment and utility lifecycle including URS review, DQ support, FAT, SAT, IQ, OQ, PQ execution and periodic requalification; Prepare and maintain qualification protocols, reports and technical documentation in compliance with GMP, EU-GMP and Abbott Quality System requirements; Provide technical support for investigations, deviations, CAPAs and change controls involving qualified equipment and utility systems; Support internal audits, corporate audits and regulatory inspections related to qualified equipment, facilities and utility systems; Participate in capital projects and engineering changes to ensure qualification requirements are incorporated during design, installation and commissioning phases
Seniority
Senior, hands-on IC
