Engineer - Lab Systems, Cell Therapy Devens

Bristol Myers Squibb-posted 2 months ago
$89,390 - $108,315/Yr
Full-time • Mid Level
Hybrid • Devens, MA
5,001-10,000 employees
Chemical Manufacturing
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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.

  • Lead and support administration of quality and laboratory applications including their software development life cycle activities and technical support.
  • Provide ownership of assets and utilize BMS systems to support changes, incidents, problems, and asset management activities for the support of benchtop equipment and lab and quality systems.
  • Create, execute and update documentation for the support of benchtop equipment and lab and quality systems to ensure assets are reliable, accessible, and secure.
  • Execute and/or lead multiple projects and technical work assignments as a point of contact for project stakeholders.
  • Lead or provide supporting activities within the quality management system (Infinity).
  • Liaison with global partners within the BMS organization to align on solutions and implementation plans for benchtop instrumentation and performs system installations, configurations, administrative and support functions including system validation lifecycles and training.
  • Provide local administrative support and liaison with global partners for the site quality systems and quality control supporting applications completing tasks such as application periodic reviews, user access reviews, and account administration.
  • Provide digital plant subject matter expertise (SME), to multi-function teams, advises operations on application configurations, data integrity, cyber security, and defend work before regulatory agencies.
  • Ensure alignment with BMS directives and industry guidelines for applications.
  • Execute on technology improvements and efficiency opportunities to improve business and compliance.
  • Provide on-call support, as needed, for commercial operations.
  • 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.
  • Comprehensive knowledge of Data Integrity guidance, GxP compliance, Software Development Life Cycle, and Good Documentation Practices.
  • 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.
  • Demonstrated leadership skills and the ability to negotiate in a complex environment.
  • Excellent verbal and written communication skills.
  • The ability to plan and lead small and medium size projects and enhancements.
  • Self-driven and capable of prioritizing.
  • Have an expanding 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.
  • Medical, pharmacy, dental and vision care.
  • Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
  • Financial well-being resources and a 401(K).
  • Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
  • Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
  • Parental, caregiver, bereavement, and military leave.
  • Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
  • Other perks like tuition reimbursement and a recognition program.
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