Automation Systems Administrator (Historian)
Regeneron Pharmaceuticals Inc

Job Info

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As an Automation Systems Administrator, you will be embedded in a tight-knit team responsible for administration of data acquisition, archival, and reporting systems to demonstrate compliance with cGMP and procedural requirements. Our team collects electronic information from Regeneron's biopharmaceutical manufacturing process and archives it to maintain a record of system performance. We collaborate with the process analysts and engineers to develop reporting solutions to support manufacturing operations.

As an Automation Systems Administrator, a typical day might include:

• Setup and management of electronic data capture and archival systems.
• Development and support of reporting and remote notifications.
• Collaborating with and supporting multiple departments interfacing data analytics software with the data historian.
• Supporting system SAT (Site Acceptance Testing) / FAT (Factory Acceptance Testing), validation and qualification efforts.
• Reviewing system lifecycle design documentation.
• Ensuring systems remain in a validated state by processing change control requests for system configurations, including requirement and/or design specifications, test plans, technical evaluation and risk assessments.
• Drafting, approving and following relevant system software SOPs and policies.
• Initiating, authoring, and reviewing documents such as Change Controls, investigations, deviations, risk assessments, impact statements and corrective/prevention action plans.
• Participating in, leading, or authoring investigations and root cause analysis for department issues of non-compliance.
• Supporting troubleshooting and investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software.
• Supporting engineering, validation, and data analytics projects.

This role might be for you if you:

• Have a solid grasp of System Design Lifecycle and Quality Risk Management.
• Enjoy crafting sustainable solutions to sophisticated issues.
• Understand process control systems and data acquisition and reporting systems.
• Are familiar with regulatory and quality policies, procedures and documentation methods, ideally in cGMP biotech/pharma operations.

Applicants ideally should have a BS/BA in Science, Engineering or related field and 2+ years of relevant experience. Without a degree we will consider at least 5 years of relevant experience in lieu of the educational requirement. Applicants with a BS/BA in Science, Engineering or related field and 5+ years of relevant experience (or 8+ years with no BS/BA degree) will be considered for a Senior level title. Principal level candidates will need at least 8 years of relevant experience with a BS/BA. We may also consider candidates with a relevant BA/BS and no experience for an Associate Automation Systems Administrator. Level will be determined based on qualifications relevant to the role.

We use Allen-Bradley control system products, OSI PI and GE Proficy data historians, and video graphic chart recorders; specific knowledge with these products is ideal.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

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