Senior Lab Automation Engineer – GxP, CSV & Compliance

United Pharma; Massachusetts; On-site; USD 120,000 - 170,000; Full time

Job summary

United Pharma is seeking an experienced Senior Lab Automation Engineer to support the global laboratory automation platform in a GxP-regulated environment. You will configure, maintain, and validate systems integral to high-throughput workflows and biologics operations.

The role emphasizes integration with analytics, instrument qualification, and adherence to 21 CFR Part 11, GMP, data integrity, and cybersecurity. Collaboration with cross-functional teams and audit readiness are essential.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, Information Technology, or a related field.
• 5+ years of experience supporting pharmaceutical laboratory operations, laboratory informatics, analytical systems, instrument qualification, or laboratory IT.
• Working knowledge of bench top instrumentation and laboratory systems supporting biologics and/or cell therapy.
• Strong understanding of CSV, GMP, 21 CFR Part 11, GAMP 5, data integrity, and cybersecurity.
• Strong troubleshooting, documentation, communication, project coordination, and end-user training skills.
• Knowledge of FDA, ISO, ICH, and other applicable regulatory guidelines.

Responsibilities

• Configure, maintain, and troubleshoot laboratory automation software, equipment, and system integrations.
• Support GxP system implementations, upgrades, configuration changes, IQ/OQ, qualification, requalification, and CSV activities.
• Maintain system configuration records, software versions, architecture documentation, and validation documentation.
• Troubleshoot technical issues, implement minor software enhancements, and provide end-user training.
• Support laboratory workflows, high-throughput methods, biologics/cell therapy operations, and audit readiness.

Skills

Lab automation

Troubleshooting

Documentation

Project coordination

End-user training

Biologics knowledge

Education

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

Job description

United Pharma is seeking an experienced Senior Lab Automation Engineer to support the global laboratory automation platform in a GxP-regulated environment. You will configure, maintain, and validate systems integral to high-throughput workflows and biologics operations.

The role emphasizes integration with analytics, instrument qualification, and adherence to 21 CFR Part 11, GMP, data integrity, and cybersecurity. Collaboration with cross-functional teams and audit readiness are essential.