TECH SVCS - IT Lab Computing Support Specialist

Location: Devens

IT Lab Computing Support Specialist Job Number: 26-00885 Be part of a company that delivers life-changing healthcare solutions. ECLARO is looking for an IT Lab Computing Support Specialist for our client in Devens, MA. ECLARO’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world.

If you’re up to the challenge, then take a chance at this rewarding opportunity!

Position Overview:

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 Pay Rate: $43.27-$45.90/Hour If hired, you will enjoy the following ECLARO Benefits: 401k Retirement Savings Plan administered by Merrill Lynch Commuter Check Pretax Commuter Benefits Eligibility to purchase Medical, Dental & Vision Insurance through ECLARO If interested, you may contact:
Paul Quibuyen   Paul Quibuyen | Linked In Equal Opportunity

Employer:

ECLARO values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status, in compliance with all applicable laws.