Automation Systems Administrator
- Regeneron Pharmaceuticals, Inc.
- Rensselaer, New York
- Start date
- Mar 15, 2023
- Engineering, Automation Engineer
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Pharm Country, Best Places to Work
As an Automation Systems Administrator, you will be embedded in a tight-knit team responsible for administration of automated/computerized system software and firmware to meet cGMP and procedural requirements. Our team specifies software configuration for biopharmaceutical process, monitoring, and testing systems. In this critical role we evaluate new software for functional equivalence to existing software. We author test plans to demonstrate suitability of software. A significant focus of this role is supporting the authoring and maintenance of configuration specifications for cGMP automated and computerized systems in our quality control and/or manufacturing process areas.In this role, a typical day might include:
- Ensuring data is backed up or archived to ensure systems can meet defined RTO (Recovery Time Objective) and RPO (Recovery Point Objective).
- Utilizing configuration management and recipe/method management
- Creating and maintaining configuration specifications for process control, monitoring and testing
- Supporting system SAT (Site Acceptance Testing) / FAT (Factory Acceptance Testing), validation and qualification efforts
- Reviewing system lifecycle design documentation
- Ensuring systems remain in a compliant state by processing change control requests for system configurations, including requirement and/or design specifications, test plans, technical evaluation and quality risk assessments
- Conducting system integration with existing systems (e.g. LIMS, Historian)
- Drafting, approving and following relevant system software SOPs and policies
- Providing end-user support including solving problems at the application level and hardware troubleshooting (includes working with vendors to resolve issues) and training them on system functionality
- 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
- Administering user access including control access to software systems; adding, modifying and removing users; defining user types, user groups and security settings
- Leading aspects of the work of automation contractors and providing guidance as applicable
- Thrive in a manufacturing, lab, or other regulated IT environment
- Have a solid grasp of System Design Lifecycle and Quality Risk Management
- Understand manufacturing process/supporting laboratory testing and/or regulatory requirements, related terminology and jargon commonly used in association with daily operations of a facility and the ability to use the terminology, in context, when discussing issues or generating documentation
- Enjoy crafting sustainable solutions to sophisticated issues
- Understand process control systems and product release testing systems
- Are familiar with regulatory and quality policies, procedures and documentation methods, ideally in cGMP biotech/pharma operations
- Enjoy working independently as part of a broader team with a proven focus on customer service
- Enjoy project management and have stellar organizational skills
- Have a knack for compiling documentation
Applicants ideally should have a BS/BA in Science, Engineering or related field and the following minimum relevant experience for each level:
- Associate Automation Systems Administrator: 0+ years
- Automation Systems Administrator: 2+ years
- Senior Automation Systems Administrator: 5+ years
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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
Equivalent combination of education and experience may be considered. Level will be determined based on qualifications relevant to the role.
Salary Range (annually)$55,700.00 - $121,300.00
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.
Stock Symbol: REGN
Stock Exchange: NASDAQ
- Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
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