Senior Engineer - Lab Automation

Compensation Overview

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

• 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 time frames.
• 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.

• 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., High Res Bio Solutions 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…