TECH SVCS - IT Lab Computing Support Specialist

Position Overview

Responsibilities

Qualifications

Pay

Benefits

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.

• Cook up coordination of 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).
• Coordinate 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.
• Support 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.
• Aid in 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.
• 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.
• The ability to represent the department before our stakeholders, including quality assurance and project managers.

Pay

Pay Rate: $43.27-$45.90/Hour

Benefits

• 401k Retirement Savings Plan administered by Merrill Lynch
• Commuter Check Pretax Commuter Benefits
• Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO