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
This role might be for you if you:
- 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 2+ years of relevant experience. Without a degree we will consider at least 5 years of relevant experience in lieu of the educational requirement. We may consider applicants with less than 2 years of relevant experience for an Associate level title. 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. Level will be determined based on qualifications relevant to the role.
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.
To Apply: https://www.jobg8.com/Traffic.aspx?rFkB3DfdBJqsZ4YREfIoEgu