What are the responsibilities and job description for the Technical Support Specialist position at TPI Global Solutions?
Job Title: Benchtop Support Specialist
Job Location: Bothell, WA
Project Duration: 12 months with possible extension
JOB DESCRIPTION
PURPOSE AND SCOPE OF POSITION:
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.
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
• Understanding of administration and usage of TFF systems, Nucleic Counters, Mixer, Filler, FIT, Veeva Document Management System, Infinity, ServiceNow and emerging technology is preferred.
• 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.
• Lead or provide supporting activities within the quality management system (Infinity)
• 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.
REQUIREMENTS:
The candidate should have at least 5 years of 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.
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
Top Skills:
- Experience working in a GMP environment
- Experience supporting end user Windows environment
- Cyber Security Knowledge
- Understanding and experience with Network, databases, servers, and PCs
- Knowledge of Incident, problem, and asset management
- 3 years of Experience Planning and leading small and medium-sized projects .
- 3 years of Experience Supporting multiple projects, ability to multi-task
