IT Lab Computing Support Specialist, Cell Therapy_26-02544
Job Description
Job Description
Job Title: IT Lab Computing Support Specialist, Cell Therapy
jOB ID: 26-02544
Locations: 100% onsite at Devens
Work Schedule: Mon-Fri 8 am-5 pm
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 the 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 the development of appropriate validation methodologies in collaboration with Operations Management and Quality Assurance for Client 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 manager
Company DescriptionFounded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.
Company Description
Founded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.