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
The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully - carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.
Benefits:Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans - including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).
U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.
Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.
Depending on eligibility, employees may also have access to additional time-off benefits, including 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 also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.
U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits
How We WorkWhere you work matters - because collaboration, innovation and patient impact happen in many settings. Our roles are structured across four work models: site-essential, site-by-design, field-based and remote-by-design. The model assigned to this role is based on its core responsibilities. Learn more at https://careers.bms.com/ways-of-working.
