Support Engineer
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Requirements
- Technical Support & Troubleshooting
- Both roles require hands-on support for lab/benchtop instruments, PCs, and applications, with a focus on resolving technical issues quickly.
- System & Network Administration
- Managing servers, workstations, networks, security patches, connectivity, and hardware/software environments.
- GxP / GMP Compliance & Data Integrity Knowledge
- Strong understanding of regulatory requirements (FDA/EU), data integrity, documentation practices, system validation, and work in regulated pharma/biotech environments.
- Project Management & Cross-Functional Collaboration
- Leading or supporting projects and coordinating with lab staff, quality teams, IT, manufacturing, and global partners.
- Data Management & Cybersecurity Awareness
- Backups, storage, recovery, system security, access control, and ensuring reliable, secure, compliant data handling.
- PURPOSE AND SCOPE OF POSITION:
- REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:
- Comprehensive knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices.
- 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.
- Demonstrated leadership skills and the ability to negotiate in a complex environment.
- Excellent verbal and written communication skills.
- The ability to plan and lead small and medium size projects and enhancements.
- The candidate needs to be self-driven and capable of prioritizing.
- The candidate should have an expanding understanding of network, databases, servers, and PCs.
- Understanding of administration and usage of TFF systems, Nucleic Counters, Mixer, Filler, FIT, Veeva Document Management System, Infinity, ServiceNow and emerging technology is preferred.
- Ability to apply lean and OpEx principles.
- The successful candidate will possess the professionalism and technical competency required to represent the department before our stakeholders, regulatory agencies, and management.
- Education and Experience:
- Bachelor's degree in life sciences, engineering or computer field or equivalent experience.
- 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 preferred.
- Demonstrated track record of IT Support in a fast-paced regulated environment supporting benchtop instruments, quality and lab applications
- DUTIES AND RESPONSIBILITIES:
- 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 buildings.
- Support administration of quality and laboratory applications including their software development life cycle activities and technical support.
- Provide ownership of assets and utilize BMS systems to support changes, incidents, problems, and asset management activities for the support of benchtop equipment and lab and quality systems.
- Execute and update documentation for the support of benchtop equipment and lab and quality systems to ensure assets are reliable, acces
Additional Information
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.
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