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RENSS - MENANDS, United States of America
Onsite
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 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. If you have any questions, please speak with your recruiter.
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. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
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)
$78,700.00 - $150,600.00