Benchtop Support Specialist
Libertyville, IL US
Benchtop Support Specialist
Duration: 12+ month contract
Location: Libertyville, IL (Onsite)
- 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.
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.
- 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.
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 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.
- 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 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.
- Provide on-call support, as needed, for commercial operations.
- Bachelor’s degree in life sciences, engineering or computer field or equivalent experience.