Orion Innovation
Support Engineer
Massachusetts, United States
Sponsorship not specifiedDetected 22 days ago
ExpressOperations ManagementFDA RegulatoryMedical DevicesCommunicationCollaborationGxP
About the role
- Orion Innovation is a premier, award-winning, global business and technology services firm.
Responsibilities
- Coordinate Lead and support administration of quality and laboratory applications including their software development life cycle activities and technical support.
- Perform PC build and configuration, including connecting to the network, setting up user permissions, folder permissions, and any interface data connections (including data backup)
- Perform Equipment/Instrument configuration for existing equipment/instrumentation and new equipment/instrumentation. This includes working with vendors and drafting specification documentation.
- Provide support for Benchtop IT and Lab Systems programs and system maintenance activities.
- Ensure that Benchtop IT and Lab Systems standard operating procedures (SOPs) and procedural methodologies employed to maintain the validated state are regularly reviewed and updated, as needed.
- Orion delivers game-changing business transformation and product development rooted in digital strategy, experience design, and engineering, with a unique combination of agility, scale, and maturity.
Requirements
- BS degree in life sciences, engineering or computer field or equivalent experience.
- Experience in Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices (GDocP)
- Ability to apply lean and OpEx principles.
- Minimum of 2+ years of experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting.
- Demonstrated track record of IT Support in a fast-paced regulated environment supporting benchtop instruments, quality and lab applications
- Comprehensive knowledge of SOPs, cGMPs and other compliance requirements and regulatory guidelines (FDA, EU) and the know how to work and manage within a regulatory environment.
- Excellent verbal and written communication skills.
- The ability to plan and lead small and medium size projects and enhancements.
- Understanding of network, databases, servers, and PCs.
- Understanding of administration and usage of Waters NuGenesis, FCS Express, Veeva Document Management System, Infinity, ServiceNow and emerging technology is preferred.
- Represent the department before our stakeholders, including quality assurance and project managers.
- Orion is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, citizenship status, disability status, genetic information, protected veteran status, or any other characteristic protected by law.
Company info
- Review and approve validation lifecycle documents as part of CSV activities, supporting the risk assessments, specifications, pre- and post-approval of qualification testing.
Visa & Work Authorization
- race, color, creed, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, citizenship status, disability status, genetic information, protected veteran status, or any other ch
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This listing is sourced directly from Orion Innovation's careers page and normalized into a canonical job model.