Orion Innovation is a premier, award-winning, global business and technology services firm. 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. We work with a wide range of clients across many industries including financial services, professional services, telecommunications and media, consumer products, automotive, industrial automation, professional sports and entertainment, life sciences, ecommerce, and education.
Summary:
Provide support and enhancements for the administration of benchtop instrumentation applications, PC hardware, and IT administrative tools within a GxP environment. Support would encompass various instrument types such as cellometers, plate readers, and flow cytometers throughout the site which include laboratory and manufacturing areas.
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.
- Review and approve validation lifecycle documents as part of CSV activities, supporting the risk assessments, specifications, pre- and post-approval of qualification testing.
- Interact with ServiceNow to review and approve digital changes.
- 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.
- Assist in development of appropriate validation methodologies in collaboration with Operations Management and Quality Assurance for novel projects.
Qualifications:
- BS degree in life sciences, engineering or computer field or equivalent experience.
- 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
- Experience in Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices (GDocP)
- 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.
- Ability to apply lean and OpEx principles.
- 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.
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