• 3+ years of experience working in a disciplined regulated industry in the application of automated technology, particularly 21 CFR Part 11 & Part 820, ISO 13485, GAMP 5
• strong knowledge of software validation
• Experience in executing validations of application systems
• Experience with business application implementation projects, including being an active contributor on projects with deliverables per a project timeline
• Results-oriented and resourceful individual with good interpersonal skills
• Demonstrated ability to interact and communicate (both oral and written), including demonstrable writing skills, speaking, and comprehension
• strong PC skills, including MS Word (advanced user), Excel, Visio, and related MS Office applications