Senior Automation System Administrator

Role Summary

Senior Automation System Administrator responsible for the administration of automated/computerized system software and firmware to meet cGMP and policy requirements. The role involves configuring software for biopharmaceutical processes, monitoring, and testing systems, evaluating new software for functional equivalence, validation activities, and maintaining system qualification through lifecycle change control.

Responsibilities

• Administering system applications including user control access, adding/modifying/removing users, defining user types, user groups and security settings.
• Monitoring data backup or archival to ensure systems 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 Site Acceptance Testing (SAT) / Factory Acceptance Testing (FAT), validation and qualification efforts.
• Conducting system integration with existing systems (e.g., LIMS, Historian).
• Processing change control requests to keep systems compliant, including requirements/design specs, test plans, technical evaluations, and quality risk assessments.
• Providing end-user support including training, application-level problem solving, and hardware troubleshooting (including working with vendors).
• Participating in, leading, or authoring investigations and root cause analyses for non-compliance issues.
• Leading aspects of work for contractors and providing guidance as applicable.

Qualifications

• This Role Might Be For You If You:
  • Have experience with Ignition, MQTT brokers, HiveMQ, HighByte, or similar platforms.
  • Are interested in manufacturing processes within a regulated technical environment.
  • Have a solid understanding of System Design Lifecycle and Quality Risk Management.
  • Enjoy designing and implementing sustainable technical/procedural solutions in a complex environment.
  • Understand process control systems and product release testing systems.
  • Are familiar with regulatory and quality policies, procedures, documentation methods.
  • Enjoy working independently as part of a broader team with a focus on customer service and maintaining compliance.
  • Enjoy project management and have strong organizational skills.
  • Are motivated to participate in continuous process improvement.
• Applicants Ideally Should Have a BS/BA in Science, Engineering or Related Field and the Following Minimum Relevant Experience:
  • Senior Automation System Administrator: 5+ years
  • Principal Automation System Administrator: 8+ years

Education

• BS/BA in Science, Engineering or Related Field (or equivalent combination of education and experience)

Skills

• Experience with Ignition, MQTT brokers, HiveMQ, HighByte, or other similar platforms
• Knowledge of regulatory and quality policies and documentation methods
• Strong problem-solving, training, and end-user support abilities
• Project management and organizational skills