IT Support Specialist

IT Support Specialist Columbia Consulting Group - 5.0 Bothell, WA Job Details Full-time | Contract $30 an hour 1 day ago Qualifications Technical documentation Pharmaceutical regulatory compliance Enterprise software Process automation manufacturing GMP Field IT support technician experience Laboratory compliance Organizational skills Quality standards in production Cross-functional collaboration Project leadership Implementing lean manufacturing processes Cross-functional communication FDA regulations SDLC Stakeholder management Full Job Description 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, 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, 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 BMS organization to align on solutions and implementation plans for benchtop instrumentation and performs system installations, configurations, administrative and support functions including system validation lifecycles and training.

Job Types:

Full-time, Contract Pay:

$30.00 per hour

Work Location:

In person