Senior GxP Systems Engineer: Compliance & Automation Lead

Avid Bioservices, Inc.; Tustin (CA); On-site; USD 94,000 - 117,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) matching

Paid time off

Job summary

Avid Bioservices, Inc. in California seeks a Senior Engineer, GxP Systems to lead the design, implementation, administration and support of enterprise systems, manufacturing equipment, and laboratory instrumentation within a GMP environment.

The role partners with project leadership to implement technology and process improvements supporting core manufacturing and quality control operations, while ensuring secure, compliant, and reliable platform operation and data integrity.

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, IT, Engineering; relevant experience may substitute on a year-for-year basis.
• 5–7 years of experience in complex systems design, administration, or regulated equipment in GMP environments.
• Experience with regulated lab/manufacturing platforms and CFR Part 11, GAMP 5, ALCOA+.

Responsibilities

• Lead and maintain system administration documentation for laboratory instruments and regulated applications.
• Develop specifications, procedures, and support documentation for GMP equipment and systems.
• Support test method development, validation, and system testing activities.
• Provide guidance for change management, deviations, CAPA, upgrades, and lifecycle management.
• Perform equipment testing and train staff on software/hardware changes.
• Provide guidance to Operations, Support, Systems Development, and vendors.
• Lead troubleshooting, coordinate vendor engagement, and resolve issues for regulated systems.
• Support security policies, access controls, and data integrity practices.
• Coordinate project activities to maximize value and minimize disruption.

Skills

Regulatory systems knowledge

Technical documentation

Project leadership

Cross-functional communication

GxP systems

Troubleshooting

Education

Bachelor's degree in Life Sciences, Computer Science, IT, Engineering

Tools

Empower 3

Emerson DeltaV / DeltaV Mobile

Rockwell FactoryTalk

Cytiva UNICORN

Sartorius MFCS/BioBrain

Sartocheck 4/5

Backups - Veeam / Acronis

Job description

Avid Bioservices, Inc. in California seeks a Senior Engineer, GxP Systems to lead the design, implementation, administration and support of enterprise systems, manufacturing equipment, and laboratory instrumentation within a GMP environment.

The role partners with project leadership to implement technology and process improvements supporting core manufacturing and quality control operations, while ensuring secure, compliant, and reliable platform operation and data integrity.