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About the Role

Regeneron is seeking a Senior Automation Systems Administrator to join the IOPS team, providing expertise in the configuration and administration of automated and computerized system software and firmware across manufacturing and laboratory operations. This role ensures systems remain compliant and validated, leads projects, drives continuous improvement, and delivers advanced technical support while collaborating with cross-functional teams. Contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

Responsibilities

Configure and maintain cGMP software for process control, monitoring, and testing.
Manage user access, system security, configuration management, and recipe and method management to meet regulatory requirements.
Determine data backup and archive requirements and configurations to meet defined RTO and RPO targets.
Design and maintain recovery processes.
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.
Support and lead system SAT/FAT, validation, and qualification efforts.
Generate and execute testing and qualification protocols for automated process, monitoring, and testing equipment.
Initiate, author, and review Change Controls, EOEs, NOEs, DNFs, risk assessments, impact statements, and corrective and preventive action plans.
Lead investigations and root cause analyses for non-compliance issues.
Lead multiple small to medium-sized projects related to corrective action, software performance improvement, and new equipment and software implementation.
Provide advanced technical automation support and troubleshooting to Manufacturing, Quality Control, and Facilities in accordance with established SOPs and departmental practices.
Support system integration with existing platforms such as LIMS and Historian.
Draft, approve, and follow relevant system software SOPs and policies.
Identify opportunities for continuous improvement in processes, procedures, and architecture standards.

Requirements

Direct experience in a pharmaceutical or biopharmaceutical manufacturing facility preferred.
Advanced experience configuring and troubleshooting process control, monitoring, and product release testing systems including design and installation.
Expertise in developing Software Lifecycle Documentation, software design documents, technical evaluations, and test plans for cGMP process equipment following GAMP 5 guidelines.
Current knowledge of cGMP biotech and pharma operations, regulatory and quality policies, procedures, and documentation methods.
BS/BA in Science, Engineering, or a related field with 5+ years of relevant experience.
May consider equivalent combination of education and experience.
Background checks may be conducted in accordance with the laws of the country where the position is based.
Background checks may verify information such as identity, right to work, and educational qualifications.

Skills

Automation Systems Administration
cGMP Software Configuration
System Security Management
Configuration Management
Recipe and Method Management
Data Backup and Archive
Recovery Process Design
Change Control Processing
System SAT/FAT
Validation and Qualification
Testing and Qualification Protocol Execution
Root Cause Analysis
Project Leadership
Technical Automation Support
Troubleshooting
System Integration (LIMS, Historian)
SOP Development and Adherence
Process Improvement
GAMP 5 Guidelines
Biotech and Pharma Operations
Regulatory and Quality Policies

Location

Menands, New York, United States

Work Type

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

Experience Level

Senior
5+ years of relevant experience

Education Level

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

Salary/Compensations

$78,700.00 - $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

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.
Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories.
Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases.
Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.

Equal Opportunity

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.