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About the Role

Regeneron is seeking an Automation System Administrator to join the IOPS team, supporting the administration and compliance of automated and computerized system software and firmware in a biopharmaceutical manufacturing environment. This role involves specifying and maintaining software configurations for process, monitoring, and testing systems, ensuring compliance throughout their lifecycle, and collaborating with cross-functional teams.

Responsibilities

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.

Requirements

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.
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.

Skills

System administration
User access control
Data backup and archival
Configuration management
Recipe management
Method management
System integration
Change control processing
System SAT/FAT
Validation
Qualification
Root cause analysis
End-user support
Troubleshooting
Process improvement
Software evaluation
cGMP environment

Location

Menands, New York, United States

Work Type

On-site
Monday - Friday 8am - 4:30pm

Experience Level

2+ years of relevant experience
5+ years of relevant experience

Education Level

BS/BA in Science, Engineering, or a related field

Salary/Compensations

$67,400.00 - $128,700.00

Benefits

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
Family support benefits

About the Company

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases.
We are committed to building a workplace with an inclusive culture.
We believe we do our best work when we are together.

Equal Opportunity

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.