Support Engineer
Listed on 2026-07-08
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Business
Regulatory Compliance Specialist
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.
Skills- 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.
The Benchtop Support specialist position will be responsible for providing IT support in our Digital Plant organization working to support, enhance, and maintain compliance for the GxP benchtop systems and instrumentation as well as site and global applications used within the manufacturing, quality, and quality control organizations. This position requires a passion for IT, validation, and compliance. Project management and business analyst skillsets within the role as the position requires the ability to work with diverse cross‑functional teams in a highly matrix organization.
The candidate should have experience in pharma/biotech with experience in Laboratory equipment, benchtop instrumentation and Quality System disciplines. The candidate needs to understand shop floor activities, Good Manufacturing Practices (GMPs), electronic change management, and process automation in addition to prior manufacturing enterprise systems support.
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, Service Now 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.
- 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 familiar with 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.
- Provide support and enhancements for the administration of benchtop instrumentation…
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