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 (Life Sciences)
Builds
Validation protocols, commissioning/qualification documents, and project deliverables for pharmaceutical equipment, processes, utilities, and facilities.
Domain
Life Sciences / Pharmaceutical / Medical Device / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Validation of automation, packaging, cleaning, computer systems, utilities, and facilities; Risk assessment; FDA compliance documentation; FAT/SAT/IQ/OQ documentation; Project lifecycle management; Technical writing
Preferred skills
Experience with entire project lifecycle from concept through startup; Digital Validation Tools
Technologies
Microsoft Office, Microsoft Project, AutoCAD
Responsibilities
Establish User Requirement Specifications; Develop and execute validation and FDA compliance documents; Prepare, execute, and manage commissioning and qualification documents; Conduct investigations and troubleshoot validation-related issues; Lead client relationship development and project execution; Manage project plans, resources, budgets, and schedules
Seniority
Mid-level (2-7 years) to Senior (7+ years) to Principal (10+ years)