Senior Automation Systems Administrator, Infrastructure

Biopharma Careers; United States; On-site; USD 67,000 - 129,000; Full time

Job summary

Regeneron is seeking an Automation System Administrator to join the IOPS team in Menands, NY. You will administer and validate automated control software, manage configuration, and ensure cGMP compliance across the manufacturing environment.

The role involves collaboration with Manufacturing, Quality Control, and cross-functional teams, supporting system integrations with LIMS and Historian, and leading change-control activities while driving process improvements. On-site, Mon–Fri work schedule.

Qualifications

• Administer system applications including user access control, user groups, and security settings; monitor data backup and archival to ensure systems meet defined RTO and RPO targets
• Maintain configuration management and recipe and method management; conduct system integration with existing platforms such as LIMS and Historian
• Ensure systems remain in a compliant state by processing change control requests including requirement and design specifications, test plans, technical evaluations, and quality risk assessments
• Author impact statements, Configuration Specifications, risk assessments, SOPs, Work Instructions, policies, and corrective and preventive action plans
• Support and lead system SAT/FAT, validation, and qualification efforts; participate in, lead, or author investigations and root cause analyses for non-compliance issues
• Provide end-user support including system functionality training, application-level troubleshooting, and hardware support in coordination with vendors
• Lead aspects of work for contractors and provide guidance as applicable; drive continuous process improvement across automation systems and procedures
• Evaluate new software for functional equivalence and support validation activities to demonstrate suitability across the system lifecycle
• Experience with process control systems and product release testing systems in a regulated manufacturing or laboratory environment preferred
• Familiarity with Ignition, MQTT brokers, HiveMQ, HighByte, or other similar platforms a plus
• Solid understanding of System Design Lifecycle and Quality Risk Management
• Familiarity with regulatory and quality policies, procedures, and documentation methods in a cGMP environment

Responsibilities

• Administer system applications and security controls across manufacturing systems
• Support and improve change control, validation, and qualification efforts
• Collaborate with Manufacturing, QA, and IT for system lifecycle compliance
• Provide end-user training and troubleshooting for system software
• Lead contractor work streams and drive continuous process improvements
• Evaluate new software for functional equivalence and validation readiness
• Assist with SAT/FAT, risk assessments, and investigations
• Coordinate with vendors on hardware support and platform integrations

Skills

System administration

Regulatory compliance

Change control

Validation & qualification

End-user support

Education

BS/BA in Science, Engineering, or related field

Tools

Ignition

MQTT brokers

HiveMQ

HighByte

Job description

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an Automation System Administrator to join our IOPS team, supporting the administration and compliance of automated and computerized system software and firmware across our biopharmaceutical manufacturing environment. In this role, you will specify and maintain software configurations for process, monitoring, and testing systems, ensuring systems remain in a qualified and compliant state throughout their lifecycle, while collaborating with Manufacturing, Quality Control, and cross-functional teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

Location: Menands, New York, United States

Work model/flexibility: Monday - Friday 8am - 4:30pm

Discover your role:

• Administer system applications including user access control, user groups, and security settings; monitor data backup and archival to ensure systems meet defined RTO and RPO targets
• Maintain configuration management and recipe and method management; conduct system integration with existing platforms such as LIMS and Historian
• Ensure systems remain in a compliant state by processing change control requests including requirement and design specifications, test plans, technical evaluations, and quality risk assessments
• Author impact statements, Configuration Specifications, risk assessments, SOPs, Work Instructions, policies, and corrective and preventive action plans
• Support and lead system SAT/FAT, validation, and qualification efforts; participate in, lead, or author investigations and root cause analyses for non-compliance issues
• Provide end-user support including system functionality training, application-level troubleshooting, and hardware support in coordination with vendors
• Lead aspects of work for contractors and provide guidance as applicable; drive continuous process improvement across automation systems and procedures
• Evaluate new software for functional equivalence and support validation activities to demonstrate suitability across the system lifecycle
• Experience with process control systems and product release testing systems in a regulated manufacturing or laboratory environment preferred
• Familiarity with Ignition, MQTT brokers, HiveMQ, HighByte, or other similar platforms a plus
• Solid understanding of System Design Lifecycle and Quality Risk Management
• Familiarity with regulatory and quality policies, procedures, and documentation methods in a cGMP environment

This role requires:

• BS/BA in Science, Engineering, or a related field
• Automation Systems Administrator: 2+ years of relevant experience
• Senior Automation Systems Administrator: 5+ years of relevant experience
• May consider equivalent combination of education and experience. Level is determined based on qualifications relevant to the role

Does this sound like you? We are committed to building a workplace with an inclusive culture.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on-site.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$67,400.00 - $128,700.00