Summary:

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 areas.

Responsibilities:

• Coordinate Lead and support administration of quality and laboratory applications including their software development life cycle activities and technical support.
• Perform PC build and configuration, including connecting to the network, setting up user permissions, folder permissions, and any interface data connections (including data backup)
• Perform Equipment/Instrument configuration for existing equipment/instrumentation and new equipment/instrumentation. This includes working with vendors and drafting specification documentation.
• Review and approve validation lifecycle documents as part of CSV activities, supporting the risk assessments, specifications, pre- and post-approval of qualification testing.
• Interact with ServiceNow to review and approve digital changes.
• Provide support for Benchtop IT and Lab Systems programs and system maintenance activities.
• Ensure that Benchtop IT and Lab Systems standard operating procedures (SOPs) and procedural methodologies employed to maintain the validated state are regularly reviewed and updated, as needed.
• Assist in development of appropriate validation methodologies in collaboration with Operations Management and Quality Assurance for novel projects.

Qualifications:

• BS degree in life sciences, engineering or computer field or equivalent experience.
• Minimum of 2+ 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
• Experience in Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices (GDocP)
• 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.
• Excellent verbal and written communication skills.
• The ability to plan and lead small and medium size projects and enhancements.
• Understanding of network, databases, servers, and PCs.
• Understanding of administration and usage of Waters NuGenesis, FCS Express, Veeva Document Management System, Infinity, ServiceNow and emerging technology is preferred.
• Ability to apply lean and OpEx principles.
• Represent the department before our stakeholders, including quality assurance and project managers.