Job Description :
Title: Validation Engineer
Location: Princeton, NJ
Duration: Fulltime


BA/BS degree in Computer Science or Software Engineering.
6+ years of relevant experience in pharmaceutical/medical device industry.
Experience with UDI implementation is a plus.
Ability to be involved in multiple full project implementations from project planning to go live especially for ERP systems (Oracle
Thorough understanding of the principles of Computer systems validation, SDLC methodologies and testing best practices.
Knowledge of GxP, GAMP5, 21CFR Part11, Eudralex Annex 11 and industry best practices.
Experience developing, executing and reviewing validation protocols and deliverables.
Software change management experience in the pharmaceutical and/or medical device industries.
Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
Strong communication and interpersonal skills and the ability to interact with the business, peers and vendors in a professional manner.
Ability to work independently with minimal supervision.