Senior Automation System Administrator

Regeneron Pharmaceuticals • Town of Colonie, NY

1d • Onsite

About The Position

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 critical role our team specifies and maintains software configuration for biopharmaceutical process, monitoring, and testing systems. This involves evaluation of new software for functional equivalence, validation activities to demonstrate suitability of software/process and maintaining the qualified state of systems throughout their lifecycle through change control. In this role, a typical day might include: 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 (Recovery Time Objective) and RPO (Recovery Point Objective). Utilizing configuration management and recipe/method management. Authoring documents such as impact statements, Configuration Specifications, risk assessments, Standard Operating Procedures, Work Instructions, Policies, and corrective/prevention action plans. Supporting system SAT (Site Acceptance Testing) / FAT (Factory Acceptance Testing), 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 (includes 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.

Requirements

• Have experience with a combination of the following: Ignition, MQTT brokers, HiveMQ, HighByte, or other similar platforms.
• Have interest in manufacturing process 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 proven 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 for each level: Senior Automation System Administrator: 5+ years

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 (Recovery Time Objective) and RPO (Recovery Point Objective).
• Utilizing configuration management and recipe/method management.
• Authoring documents such as impact statements, Configuration Specifications, risk assessments, Standard Operating Procedures, Work Instructions, Policies, and corrective/prevention action plans.
• Supporting system SAT (Site Acceptance Testing) / FAT (Factory Acceptance Testing), 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 (includes 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.

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees