Senior Lab Automation Engineer – GXP/CSV Specialist

Bristol-Myers Squibb

Harvard (MA)

On-site

USD 99,000 - 121,000

Full time

3 days ago

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Benefits offered by this job

Flexible Time Off

11 paid company holidays

Wellbeing support

Insurance offerings

Global Shutdown holidays

Job summary

Bristol Myers Squibb in Devens, MA is seeking a Senior Engineer for Lab Automation who will manage lab automation software and qualified systems on the manufacturing floor. You will support IQ/OQ activities, document configurations, and mentor teams on procedures and security practices.

Ideal candidates have 5+ years in pharma lab operations and strong knowledge of CSV, GMP, FDA guidelines, and cyber security. This role offers comprehensive benefits and on-site work in Massachusetts.

Qualifications

Bachelor's degree with ≥5 years in pharma lab ops, informatics, or instrument qualification.
Hands-on experience configuring automation software and system integrations.
Knowledge of benchtop instrumentation and quality systems in Biologics/Cell Therapy.
Experience configuring systems for lab workflows and high-throughput methods.
Experience deploying and troubleshooting integrated automation software (HighRes/Cellario).
Ability to mentor staff on documentation and technical processes.
Ability to lead multiple concurrent projects with SMEs.
Knowledge of data integrity, cyber security, and computer system validation (21 CFR Part 11, GAMP 5).
Strong troubleshooting and problem-solving skills.
Effective communication with Quality, Manufacturing, Validation, and Digital Plant teams.
Knowledge of CSV, GMP, FDA, GAMP, ISO, ICH and related standards.
Strong attention to safety in all activities.

Responsibilities

Execute & manage documentation for lab automation equipment and software.
Configure, maintain, and support computerized systems and software on the lab floor.
Support system implementations, upgrades, and validation documentation (IQ/OQ).
Optimize configurations, implement minor software enhancements, investigate issues.
Support qualification and requalification activities and end-user training.
Collaborate with method automation SMEs to support lab automation systems.
Develop and maintain documentation on configurations and system architecture.
Provide end-user support for system/software issues site-wide.
Provide end-to-end support for changes, incidents, problems, and asset management.
Lead multiple projects as a point of contact for stakeholders.
Offer SME guidance on configurations, data integrity, and cyber security.
Define and execute technology and efficiency opportunities for compliance.
Develop methodologies with matrix teams and leadership.
Ensure alignment with validation directives and industry guidelines.