Validation Engineering Roles
Core
Support capital project CQV delivery and technical solutions for clients in the Life Sciences industry, focusing on validation, compliance, and FDA regulations for pharmaceutical equipment and processes.
Role type
Validation Engineer / Senior Validation Engineer / Sr. Project Manager
Builds
Pharmaceutical and medical device manufacturing facilities, automation systems, and utility/process equipment
Domain
Life Sciences / Pharmaceutical Manufacturing / Regulatory Compliance
Required skills
Validation of automation and packaging systems, User Requirement Specifications (URS) development, risk assessment, FDA compliance documentation, FAT/SAT/IQ/OQ execution, commissioning and qualification, technical writing, project lifecycle management
Preferred skills
Experience with drug substance and drug product systems, full project lifecycle from concept to startup, proficiency with Digital Validation Tools
Technologies
Microsoft Office, Microsoft Project, AutoCAD, Digital Validation Tools
Responsibilities
Assist in basic and conceptual design phases by embedding compliance and testability; Develop and execute validation protocols and FDA compliance documents; Prepare, execute, and manage commissioning and qualification documents; Conduct investigations and troubleshoot validation 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)