Benchtop Support Specialist - LanceSoft Inc

Role: Benchtop Support Specialist
Location: Libertyville, IL, 60048
Duration: 12 months

Must Have List:

• 8+ years of experience working in regulated industries such as Biotech or Pharmaceutical. Comprehensive knowledge of SOPs, cGMPs and other compliance and regulatory guidelines (FDA, EU).
• 8+ years with Medical Devices familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting.
• 8+ years of experience with IT Support in a fast-paced regulated environment supporting benchtop instruments, quality, and lab applications.
• Comprehensive knowledge of Data Integrity guidance, GxP Compliance, SDLC and Good Documentation Practices
• Understanding of administration and usage of TFF systems, Nucleic Counters, Mixer, Filler, FIT, network database, and emerging technology is preferred.

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. 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 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.

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.
• Minimum of 5+ years of 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.
• 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 client s 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 s 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.
• 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 s 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.