Automation System Administrator

Role Summary

As an Automation System Administrator, you will be embedded in a tight-knit team responsible for administration of automated system software and firmware to meet cGMP and policy requirements. You will specify and maintain software configuration for biopharmaceutical process, monitoring, and testing systems, evaluate new software for functional equivalence, and support validation activities to demonstrate suitability of software and processes, maintaining the qualified state of systems throughout their lifecycle through change control.

Responsibilities

• Administering system applications including user control access; adding, modifying, and removing users; defining user types, user groups and security settings.
• Monitoring data backup or archival to ensure systems can meet defined RTO and RPO.
• Utilizing configuration management and recipe/method management.
• Authoring documents such as impact statements, Configuration Specifications, risk assessments, SOPs, Work Instructions, Policies, and corrective/prevention action plans.
• Supporting system SAT/FAT, validation and qualification efforts.
• Conducting system integration with existing systems (e.g. LIMS, Historian).
• Ensuring systems remain in a compliant state by processing change control requests for system configuration, including requirement and/or design specifications, test plans, technical evaluation, and quality risk assessments.
• Providing end-user support including system functionality training, solving problems at the application level and hardware troubleshooting (including working with vendors to resolve issues).
• Participating in, leading, or authoring investigations and root cause analysis for issues of non-compliance.
• Leading aspects of the work for contractors and providing guidance as applicable.

Qualifications

• Required: 2+ years of experience for Automation System Administrator role
• Required: 5+ years of experience for Senior Automation System Administrator role
• Equivalent combination of education and experience may be considered. Level will be determined based on qualifications relevant to the role.

Education

• BS/BA in Science, Engineering Or Related Field