Validation Engineering Roles
Core
Support capital project CQV delivery and technical solutions for clients in the Life Sciences industry, focusing on validation, compliance, and project management for pharmaceutical and medical device environments.
Role type
Validation Engineer / Sr. Validation Engineer / Sr. Project Manager / CSV Engineer
Builds
Pharmaceutical and medical device manufacturing systems, utilities, facilities, and automated processes
Domain
Life Sciences / Pharmaceutical / Medical Devices / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation of automation, packaging, drug substance, and drug product systems; User Requirement Specifications development; Risk assessment for system functions; FDA compliance documentation; Commissioning and qualification (FAT, SAT, IQ, OQ); Investigation and troubleshooting of validation issues; Project lifecycle management; Technical writing
Preferred skills
Experience with entire project lifecycle from concept to startup; Proficiency with Microsoft Project and AutoCAD
Technologies
Emerson DeltaV, Syncade, Allen Bradley PLC, Wonderware, OSI PI, Rockwell software platform
Responsibilities
Assist in basic and conceptual design phases by embedding compliance and lifecycle thinking; Develop and execute validation and FDA compliance protocols; Prepare, execute, and manage commissioning and qualification documents; Conduct investigations and troubleshoot validation-related issues; Lead client relationship development and project execution; Manage project resources, budgets, and schedules
Seniority
Mid-level (2-7 years) to Senior (7+ years) to Principal (10+ years)
