Support Engineer

Responsibilities

• Coordinate and support administration of quality and laboratory applications including SDLC activities
• Perform PC build and configuration, including network connectivity, user permissions, and data backups
• Configure existing and new equipment/instrumentation in collaboration with vendors
• Review and approve validation lifecycle documents as part of CSV activities
• Interact with ServiceNow to review and approve digital changes
• Provide support for Benchtop IT and Lab Systems programs and maintenance
• Ensure SOPs and procedural methodologies maintain the validated state
• Assist in developing validation methodologies for novel projects

Requirements

• BS degree in life sciences, engineering, or computer field or equivalent experience
• 2+ years of experience in regulated industries (Biotech, Pharma, or Medical Devices)
• Experience supporting benchtop instruments and applications in GxP environments
• Knowledge of Data Integrity, GxP compliance, SDLC, and Good Documentation Practices (GDocP)
• Understanding of SOPs, cGMPs, and regulatory guidelines (FDA, EU)
• Understanding of networks, databases, servers, and PCs
• Strong verbal and written communication skills
• Ability to lead small to medium-sized projects

Preferred Qualifications

• Experience with Waters NuGenesis, FCS Express, Veeva Document Management System, Infinity, or ServiceNow
• Ability to apply lean and OpEx principles

About the Company

Orion Innovation is a premier, award-winning, global business and technology services firm delivering business transformation and product development across various industries including life sciences and financial services.