Senior Engineer - Lab Automation

Bristol Myers Squibb • Devens, MA

7d • $99,480 - $120,551

About The Position

The Senior Engineer - Lab Automation supports laboratory automation equipment, software, and computerized systems in GXP laboratories and on the manufacturing floor. The role configures, maintains, troubleshoots, and improves automation software and hardware, including orchestration and scheduling software, instrument drivers, and system integrations. It also supports system implementations, upgrades, configuration changes, qualification, requalification, and computer system validation, with associated documentation such as requirements gathering, IQ, and OQ.

The position provides technical support and training to end users, maintains documentation on configurations, software versions, and system architecture, and advises cross-functional teams on system configuration, data integrity, cybersecurity, and validation. The engineer leads multiple projects and technical assignments, supports audits and inspections, and provides on-call coverage as needed for 24/7 commercial operations. The role is based in Devens, Massachusetts; the posting does not specify a work model for this position.

Requirements

• Bachelor's degree in Life Sciences, Chemistry, Engineering, Information Technology, or a related field.
• At least 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, such as Hamilton Venus, including troubleshooting and version and configuration management.
• Working knowledge of benchtop instrumentation and laboratory and quality systems supporting Biologics and/or Cell Therapy operations.
• Experience configuring and supporting computerized systems and software for laboratory workflows and high-throughput methods in the biotechnology or pharmaceutical industry, in partnership with method automation and equipment subject matter experts.
• Experience configuring, deploying, and troubleshooting integrated automation software, including laboratory orchestration and scheduling software such as HighRes BioSolutions systems and the 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, cybersecurity, 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.

Responsibilities

• Execute and manage documentation and processes that support laboratory automation equipment and related software, ensuring assets are reliable, accessible, and secure.
• Configure, maintain, and support computerized systems and software, including orchestration and scheduling software, instrument drivers, system integrations, and underlying automated hardware and software used in GXP laboratories and on the manufacturing floor.
• Support computerized system implementations, upgrades, and configuration changes, including documentation for requirements gathering, IQ, OQ, and computer system validation.
• Optimize computerized system configurations, implement minor software enhancements, and support technical investigations into 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 subject matter experts and other automation team members to support and maintain laboratory automated systems.
• Develop and maintain documentation about computerized system configurations, software versions, and system architecture.
• Provide technical support to site end users and stakeholders for system- and software-related issues.
• Own end-to-end support in BMS systems used for changes, incidents, problems, and asset management, ensuring 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 to multifunctional teams and advise operations on application configurations, data integrity, and cybersecurity.
• 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 internal and external audits and inspections.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan eligibility and terms.
• Flexible Time Off for eligible U.S.-based exempt employees, subject to manager approval.
• Paid company holidays.
• For specified non-exempt, RayzeBio, and Puerto Rico employees: 160 hours of paid vacation annually for new hires, subject to manager approval, and 3 optional holidays.
• Depending on eligibility, paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
• Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year's Day.
• Potential eligibility for discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior