IT Lab Computing Support Specialist

Job Title: IT Lab Computing Support Specialist

Location:

100% onsite at Devens, MA
Duration: 6 months with possible extension
Pay Rate: $42.37/hr

Top Requirements:
" Experience in the pharmaceutical industry working in a regulated GMP environment
"

Experience with the administration of IT/computer systems
"

Experience with PC build and configuration
" Experience configuring equipment for GMP manufacturing

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 cello meters, 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 Service Now 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 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, Service Now and emerging technology is preferred.
" Ability to apply lean and OpEx principles.
" Represent the department before our stakeholders, including quality assurance and project managers