Senior Engineer - Lab Automation
Bristol Myers Squibb
Summary
Execute & manage documentation and processes for the support of lab automation equipment and related software to ensure assets are reliable, accessible, and secure.
Job description
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
- 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
- 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
Benefits
- Wellbeing Support
- Retirement Benefits
- Financial Protection Benefits
- Medical, Dental & Vision
- Life & Disability Insurance
- Flexible Time Off
- 11 Paid Company Holidays
- Paid Sick Leave
- Volunteer Days
- Summer Hours Flexibility
- Leaves of Absence
- Annual Global Shutdown
Company overview
Bristol Myers Squibb is a global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that help patients prevail over serious diseases. Founded in 1887 and headquartered in Princeton, New Jersey, the company operates with a unique BioPharma strategy that combines the reach and resources of a major pharmaceutical company with the entrepreneurial spirit and agility of a biotech firm. BMS focuses on transformative therapies in key therapeutic areas including oncology, hematology, immunology, cardiovascular disease, and fibrosis. The company has built a sustainable pipeline of potential therapies and leverages translational medicine and data analytics to deliver the right medicine to the right patient at the right time. With over 10,000 employees worldwide, Bristol Myers Squibb maintains a strong commitment to scientific excellence, patient-centric innovation, and global health equity through its foundation. The company's portfolio includes groundbreaking treatments such as Opdivo (nivolumab) for cancer, Eliquis (apixaban) for cardiovascular conditions, and Orencia (abatacept) for autoimmune diseases, among others.