Support capital project CQV delivery and individual technical contribution solutions for clients within the Life Sciences industry
Job Summary
Support capital project CQV delivery and individual technical contribution solutions for clients within the Life Sciences industry.
Assist in design phases by embedding compliance, testability, and lifecycle thinking, and establish User Requirement Specifications for critical equipment.
Develop and execute validation and FDA compliance related documents/protocols, prepare and execute commissioning and qualification documents, and conduct investigations for validation-related issues.
Matching Summary
Support capital project CQV delivery and individual technical contribution solutions for clients within the Life Sciences industry.
Skills & Requirements
Must-have
CQV delivery
User Requirement Specifications
risk assessment
validation and FDA compliance documents
commissioning and qualification documents
FAT, SAT, IQ, and OQ documentation
client relationship development
project plans, strategies, budgets, and schedules
Nice-to-have
Truly Human Leadership culture
Digital Validation Tools
experience with entire project lifecycle
Key Requirements
Minimum 2-7 years project experience (Validation Engineer II)
Minimum 7+ years experience (Sr. Validation Engineer)
Minimum 10+ years experience (Sr. Project Manager)
Minimum 4 years computer system validation experience (CSV Engineer)
Bachelor's degree in Engineering
Proficiency with project documentation and computer skills
Work Rights
Must be legally authorized to work in the United States without sponsorship