TECH SVCS - Benchtop Support Specialist

Overview

Job Number: 26-01030

Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for a Benchtop Support Specialist for our client in Bothell, WA. ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!

Benchtop Support Specialist – Bothell, WA

• 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.
• Experience in pharma/biotech with experience in Laboratory equipment, benchtop instrumentation and Quality System disciplines.
• Needs to understand shop floor activities, Good Manufacturing Practices (GMPs), electronic change management, and process automation in addition to prior manufacturing enterprise systems support.

• 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 cello meters, 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 Client 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, accessible, and secure.
• Execute and/or leads multiple projects and technical work assignments as a point of contact for project stakeholders.
• Lead or provide supporting activities within the quality management system (Infinity).
• Liaison with global partners within the Client organization to align on solutions and implementation plans for benchtop instrumentation and performs system installations, configurations, administrative and support functions including system validation life cycles and training.
• Provide local administrative support and liaison with global partners for the site quality systems and quality control supporting applications completing tasks such as application periodic reviews, user access reviews, and account administration.
• Provide digital plant subject matter expertise (SME), to multi-function teams, advises operations on application configurations, data integrity, cyber security, and defend work before regulatory agencies.
• Ensure alignment with Client directives and industry guidelines for applications.
• Execute on technology improvements and efficiency opportunities to improve business and compliance.
• Provide on-call support, as needed, for commercial operations.

• 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.
• Self-driven and capable of prioritizing.
• Have an expanding understanding of network, databases, servers, and PCs.
• Understanding of administration and usage of TFF systems, Nucleic…