Senior Automation Systems Administrator, Infrastructure

BioSpace; Village of Menands (NY); On-site; USD 67,000 - 129,000; Full time

Job summary

Regeneron is seeking an Automation System Administrator to join the IOPS team on the manufacturing floor and in the lab. The role involves administering process control, monitoring, and testing systems, ensuring regulatory compliance, and supporting validation activities across the system lifecycle.

The position requires experience with site acceptance testing, change control, and collaboration with Manufacturing, Quality Control, and cross-functional teams.

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, a tight-knit group responsible for administering the operational technology (OT) systems that run our biopharmaceutical manufacturing environment. This is a manufacturing floor and laboratory systems role, not an enterprise IT role. You will specify and maintain software and firmware configurations for process control, monitoring, and testing systems, evaluate new software for functional equivalence, and carry out the validation activities that demonstrate its suitability. You will keep these systems in a qualified, cGMP-compliant state throughout their lifecycle through change control, working closely 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

• Administering process control, monitoring, and testing system applications, including user access control (adding, modifying, and removing users), user types and groups, and security settings
• Monitoring data backup and archival to ensure systems can meet defined RTO (Recovery Time Objective) and RPO (Recovery Point Objective) targets
• Using configuration management and recipe/method management to maintain system configurations
• Integrating manufacturing and laboratory systems with platforms such as LIMS and Historian
• Ensuring systems remain in a compliant state by processing change control requests for system configuration, including requirement and design specifications, test plans, technical evaluations, and quality risk assessments
• Authoring impact statements, Configuration Specifications, risk assessments, SOPs, Work Instructions, policies, and corrective and preventive action plans
• Supporting and leading system SAT (Site Acceptance Testing), FAT (Factory Acceptance Testing), validation, and qualification efforts
• Evaluating new software for functional equivalence and supporting validation activities across the system lifecycle
• Participating in, leading, or authoring investigations and root cause analyses for non-compliance issues
• Providing end-user support on the manufacturing floor and in the lab, including system functionality training, application-level problem solving, and hardware troubleshooting in coordination with vendors
• Leading aspects of work for contractors and providing guidance as applicable
• Driving continuous process improvement, designing and implementing sustainable technical and procedural solutions in a complex environment

Experience And Skills We Are Looking For

• Hands-on experience with process control systems and product release testing systems in a regulated manufacturing or laboratory environment
• Experience supporting OT or industrial automation systems (for example, SCADA, DCS, PLC/HMI, or manufacturing execution platforms), as opposed to enterprise IT or help desk environments
• Experience with a combination of Ignition, MQTT brokers, HiveMQ, HighByte, or similar industrial data platforms
• Solid understanding of System Design Lifecycle and Quality Risk Management
• Familiarity with regulatory and quality policies, procedures, and documentation methods in a cGMP environment
• Interest in the manufacturing process within a regulated technical environment
• Ability to work independently as part of a broader team, with a proven focus on customer service and maintaining compliance

This Role Requires

• Project management experience and strong organizational skills
• 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 comb ination of education and experience. Level is determined based on qualifications relevant to the role
• Gowning: Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire
• Ability to perform physical requirements for entirety of shift (up to 10 hours) in a clean room environment
• Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs

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.

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