Support Engineer

1 day ago
Full-time
Senior
Customer and Technical Support
Orion Innovation

Orion Innovation

Orion Innovation is a global technology services provider specializing in digital transformation, offering solutions in data, analytics, enterprise collaboration, risk & compliance, and cloud services to enhance productivity and decision-making.

IT Services
1K-5K
Founded 1993

Description

  • Provide IT support and enhancements for benchtop instrumentation applications, PC hardware, and administrative tools in a GxP environment.
  • Support quality and laboratory applications, including software development life cycle activities and technical troubleshooting.
  • Own assets and use BMS systems to manage changes, incidents, problems, and asset management for benchtop equipment and lab and quality systems.
  • Create, execute, and update documentation to support benchtop equipment and lab and quality systems.
  • Lead or support multiple projects and technical work assignments as a point of contact for project stakeholders.
  • Support the quality management system (Infinity) and related operational activities.
  • Coordinate with global partners to align on solutions, implementation plans, installations, configurations, validation lifecycles, and training.
  • Provide local administrative support for site quality systems and quality control applications, including periodic reviews, user access reviews, and account administration.
  • Advise operations and multi-functional teams on application configurations, data integrity, cybersecurity, and regulatory readiness.
  • Identify and execute technology improvements and efficiency opportunities to improve business and compliance.
  • Provide on-call support as needed for commercial operations.

Requirements

  • Bachelor’s degree in life sciences, engineering, computer field, or equivalent experience.
  • Experience in regulated industries such as biotech, pharmaceutical, or medical devices is preferred.
  • Experience supporting benchtop instruments and applications in a GxP-compliant manufacturing or laboratory setting is preferred.
  • Strong knowledge of data integrity guidance, GxP compliance, software development life cycle, and good documentation practices.
  • Strong knowledge of SOPs, cGMPs, FDA and EU regulatory requirements, and working within a regulated environment.
  • Demonstrated leadership skills and the ability to negotiate in a complex environment.
  • Excellent verbal and written communication skills.
  • Ability to plan and lead small and medium-sized projects and enhancements.
  • Self-driven with the ability to prioritize effectively.
  • Expanding understanding of networks, databases, servers, and PCs.
  • Preferred familiarity with TFF systems, Nucleic Counters, Mixer, Filler, FIT, Veeva Document Management System, Infinity, ServiceNow, and emerging technologies.
  • Ability to apply lean and OpEx principles.
  • Professionalism and technical competency to represent the department to stakeholders, regulatory agencies, and management.

Interested in this position?

Apply directly on the company website

Apply Now

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