At Bristol Myers Squibb, our employees often ask, “Who are you working for?”—a question that fuels collaboration, accountability, and urgency in our work. Our purpose-driven culture inspires us to discover, develop, and deliver innovative medicines to prevail over serious diseases. We offer uniquely interesting and meaningful work, opportunities for growth, and a supportive environment that values inclusion, wellbeing, flexibility, and comprehensive benefits.
This is work that transforms the lives of patients, and the careers of those who do it.
Responsibilities
- ✓Execute & manage documentation and processes for the support of lab automation equipment and related software to ensure assets are reliable, accessible, and secure.
- ✓Configure, maintain, and support the computerized systems and software (e.g., orchestration/scheduling software, instrument drivers, and system integrations) as well underlying automated hardware/software used in the GXP laboratory and on the manufacturing floor.
- ✓Support computerized system implementations, upgrades, and configuration changes within the GXP lab and manufacturing floor, including documentation associated with requirements gathering, IQ, OQ, and computer system validation.
- ✓Optimize computerized system configurations, implement minor software enhancements, and support technical investigations related to system-level issues.
- ✓Support computerized system qualification and requalification activities and lead end-user training on systems and workflows.
- ✓Work with method automation and equipment SMEs, as well as other automation team members, to support or maintain lab automated systems.
- ✓Develop and maintain documentation related to computerized system configurations, software versions, and system architecture used in the lab and on the manufacturing floor.
- ✓Provide technical support to end-users and stakeholders across the site for system- and software-related issues.
- ✓Provide end-to-end support and ownership within BMS systems used to support changes, incidents, problems, and asset management, and ensure all activities are completed within defined timeframes.
- ✓Lead multiple projects and technical work assignments as a point of contact for project stakeholders.
- ✓Provide subject matter expertise (SME) to multi-function teams, advise operations on application configurations, data integrity, and cyber security.
- ✓Define and execute technology and efficiency opportunities to improve business and compliance.
- ✓Develop appropriate methodologies in collaboration with matrix teams and leadership.
- ✓Ensure alignment with BMS directives and industry guidelines on validation.
- ✓Provide on-call support, as needed, for 24/7 commercial operations.
- ✓Support Quality and Manufacturing areas during audits and inspections from internal and external organizations.
Requirements
- ✓Bachelor's degree in Life Sciences, Chemistry, Engineering, Information Technology, or a related field, with a minimum of 5 years of experience in pharmaceutical laboratory operations, laboratory informatics, instrument qualification, analytical systems, or IT roles supporting laboratory environments.
- ✓Hands-on experience configuring and maintaining automation software and associated system integrations (e.g., Hamilton Venus), including troubleshooting and version/configuration management.
- ✓Working knowledge of benchtop instrumentation and laboratory/quality systems supporting Biologics and/or Cell Therapy operations.
- ✓Experience configuring and supporting computerized systems and software for laboratory workflows and high-throughput methods within the biotechnology or pharmaceutical industry, partnering with method automation/equipment SMEs who define the underlying method and equipment requirements.
- ✓Experience configuring, deploying, and troubleshooting integrated automation software, including lab orchestration/scheduling software (e.g., HighRes BioSolutions systems and Cellario platform).
- ✓Demonstrated ability to mentor and guide staff on documentation practices and technical processes.
- ✓Ability to lead and coordinate multiple concurrent projects and technical work assignments.
- ✓Working knowledge of data integrity, cyber security, and computer system validation principles, including 21 CFR Part 11 and GAMP 5 guidance for laboratory computerized systems.
- ✓Strong technical troubleshooting and problem-solving skills.
- ✓Ability to communicate effectively with cross-functional teams, including Quality, Manufacturing, Validation, and Digital Plant.
- ✓Substantial knowledge of CSV, GMP, FDA, GAMP, ISO, ICH, and other applicable standards and guidance regimes.
- ✓Strong attention to safety is a must.
We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.
Compensation Overview
Devens - MA - US: $99,480 - $120,551