Senior Engineer - Lab Automation

Bristol-Myers Squibb; United States; On-site; USD 99,000 - 121,000; Full time

Job summary

Bristol Myers Squibb is seeking a skilled automation and systems professional to support lab software, hardware, and qualification activities on the Devens, MA site. You will manage documentation, configure and validate automated systems, and mentor staff working with instrument integrations and data integrity.

You will collaborate across Quality, Manufacturing, and Validation to ensure compliance with 21 CFR Part 11, GAMP5, and related standards while leading multiple projects and providing

Qualifications

• Bachelor's degree in Life Sciences, Chemistry, Engineering, or IT with 5+ years in pharma lab ops.
• Hands-on configuring automation software and system integrations (e.g., Hamilton Venus).
• Experience with lab instrumentation and biologics/cell therapy operations.
• Familiar with 21 CFR Part 11 and GAMP 5 for lab systems.
• Ability to manage multiple projects and mentor staff.
• Strong communication with cross-functional teams.
• Knowledge of CSV, GMP, FDA, ISO, ICH standards.

Responsibilities

• Execute & manage documentation and processes for lab automation assets.
• Configure, maintain, and support computerized systems and software on the lab floor.
• Support system validation activities, including IQ/OQ, documentation.
• Optimize configurations and support investigations for system issues.
• Lead end-user training on systems and workflows.
• Collaborate with SMEs to support or maintain automated systems.
• Develop documentation on configurations, software versions, and architecture.
• Provide technical support to end-users across the site.
• Own activities for changes, incidents, problems, and asset management.
• Lead multiple projects as SME to stakeholders.
• Advise operations on configurations, data integrity, and cyber security.

Skills

Lab automation

System integrations

Cyber security

Problem solving

Education

Bachelor's degree in Life Sciences, Chemistry, Engineering, or IT

Tools

Hamilton Venus

HighRes BioSolutions

Cellario platform

Lab orchestration software

Job description

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.

Compensation Overview

Devens - MA - US: $99,480 - $120,551

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive