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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Skills Required
- BS degree in life sciences, engineering or computer field or equivalent experience
- Minimum of 2+ years of experience in regulated industries
- Track record of IT Support in a regulated environment
- Experience in Data Integrity guidance and GxP compliance
- Excellent communication skills
Orion Innovation Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Orion Innovation and has not been reviewed or approved by Orion Innovation.
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Wellbeing & Lifestyle Benefits — Orion highlights health and well-being initiatives such as fitness, mindfulness, and flexibility/remote options, reinforced by recognition like Cigna’s Healthy Workforce Designation. Flexibility via hybrid/remote work is positioned as a consistent part of the overall rewards experience.
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Fair & Transparent Compensation — Pay is characterized as moderately satisfactory overall, with pockets where compensation is viewed as fair, particularly for some software engineering and certain U.S. roles. Public snapshots also indicate that competitiveness can be stronger in specific markets and functions.
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Career-Linked Recognition & Rewards — Performance-linked outcomes are implied through mentions that hikes can be good when performance is demonstrated. Learning and development programs are also emphasized as part of the broader value proposition tied to career growth.
Orion Innovation Insights
What We Do
Orion is a leading digital transformation and product development services firm. Headquartered in Edison, NJ, we have a global team of 6,200+ associates, with engineers in 14 major delivery centers across North America, Europe, Asia Pacific and Latin America. For over 25 years, Orion has been solving complex business problems for our clients. Our transformative business solutions are rooted in digital strategy, experience design, and engineering, empowering our clients to operate with agility at scale. Our mission is to serve as an agile and trusted partner for business transformation initiatives, providing deep emerging technology, experience design, and domain expertise. Our business has more than tripled over the last three years. We have grown aggressively both organically and inorganically, adding new clients, complementary skills, domain expertise, and strengthening our global footprint.
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