Senior Automation System Specialist

As a Senior Automation System Specialist (Administrator), you will be embedded in a tight-knit team responsible for administration of automated/computerized system software and firmware to meet cGMP and policy requirements. In this critical role our team specifies and maintains software configuration for biopharmaceutical process, monitoring, and testing systems. This involves evaluation of new software for functional equivalence, validation activities to demonstrate suitability of software/process and maintaining the qualified state of systems throughout their lifecycle through change control.

In this role, a typical day might include:

• 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.

This role might be for you if you:

• Have experience with a combination of the following: Ignition, MQTT brokers, HiveMQ, HighByte, or other similar platforms.

• Have interest in manufacturing process within a regulated technical environment.

• Have a 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.

• Are 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.

• Are motivated to participate in continuous process improvement.

Applicants ideally should have a BS/BA in Science, Engineering or related field and the following minimum relevant experience for each level:

• Senior Automation System Specialist (Administrator): 5+ years

• Principal Automation System Specialist (Administrator): 8+ years

Equivalent combination of education and experience may be considered. Level will be determined based on qualifications relevant to the role.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include 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, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site.  Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
 

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, nationalit