Senior Automation System Administrator

Role Summary

As a Senior Automation System Administrator, you will be embedded in a tight-knit team responsible for administration of automated/computerized system software and firmware to meet cGMP and policy requirements. In this role our team specifies and maintains software configuration for biopharmaceutical process, monitoring, and testing systems, evaluating new software for functional equivalence, and 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 requirements/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

• Experience with a combination of the following platforms: Ignition, MQTT brokers, HiveMQ, HighByte, or other similar platforms.
• Interest in manufacturing processes within a regulated technical environment.
• Solid understanding of System Design Lifecycle and Quality Risk Management.
• Ability to design and implement sustainable technical/procedural solutions in a complex environment.
• Understanding of process control systems and product release testing systems.
• Familiarity with regulatory and quality policies, procedures, and documentation methods.
• Ability to work independently as part of a broader team with a focus on customer service and maintaining compliance.
• Project management skills and strong organizational abilities.
• Motivation to participate in continuous process improvement.

Education

• Bachelor's degree in Science, Engineering, or a related field, or equivalent combination of education and experience.
• Senior Automation System Administrator: 5+ years of relevant experience
• Principal Automation System Administrator: 8+ years of relevant experience