Automation System Administrator jobs in United States
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Regeneron · 2 days ago

Automation System Administrator

Regeneron is a biopharmaceutical company seeking an Automation System Administrator to manage automated system software and firmware in compliance with cGMP and policy requirements. The role involves software configuration management, user access administration, and ensuring compliance throughout the software lifecycle.

BiopharmaBiotechnologyPharmaceutical
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Comp. & Benefits
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H1B Sponsor Likelynote

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

Qualification

Automation software administrationSystem integrationQuality Risk ManagementIgnitionProcess control systemsRegulatory complianceCustomer serviceProject managementOrganizational skills

Required

Administration of automated/computerized system software and firmware to meet cGMP and policy requirements
Specifying and maintaining software configuration for biopharmaceutical process, monitoring, and testing systems
Evaluation of new software for functional equivalence
Validation activities to demonstrate suitability of software/process
Maintaining the qualified state of systems throughout their lifecycle through change control
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
BS/BA in Science, Engineering or related field
Minimum relevant experience of 2+ years for Automation System Administrator or 5+ years for Senior Automation System Administrator

Preferred

Experience with a combination of Ignition, MQTT brokers, HiveMQ, HighByte, or other similar platforms
Interest in manufacturing process within a regulated technical environment
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
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
Motivated to participate in continuous process improvement

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)

Company

Regeneron

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Regeneron Pharmaceuticals specializes in the discovery, development, and commercialization of innovative medicines.

H1B Sponsorship

Regeneron has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (157)
2024 (128)
2023 (128)
2022 (137)
2021 (104)
2020 (122)

Funding

Current Stage
Public Company
Total Funding
$15.93M
Key Investors
U.S. Department of Health & Human Services
2024-07-11Post Ipo Equity· $2.03M
2023-10-18Post Ipo Equity· $5M
2016-08-22Post Ipo Equity· $8.9M

Leadership Team

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Aris Baras
Senior Vice President, Regeneron Pharmaceuticals, General Manager, Regeneron Genetics Center
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Bari Kowal
Senior Vice President, Head Development Operations & Portfolio Management
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Company data provided by crunchbase