Automation Systems Administrator

Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Responsible for administration of automated/computerized system software and firmware to meet cGMP and procedural requirements. Specifies software configuration for biopharmaceutical process, monitoring, and testing systems. Evaluates new software for functional equivalence to existing software. Authors test plans to demonstrate suitability of software. Supports authoring and maintains configuration specifications for cGMP automated and computerized systems.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Ensure systems' data is backed up / archived as required to ensure system can meet defined RTO and RPO. Perform recovery of data as needed.

• Configuration management and recipe/method management.

• Creates and maintains configuration specifications for cGMP software for process control, monitoring and testing.

• Support system SAT/FAT, validation and qualification efforts.

• Review system lifecycle design documentation

• Ensure systems remain in compliant state - Process change control requests for system configurations, including requirement and/or design specifications, test plans, technical evaluation and quality risk assessments.

• System integration with existing systems (ex. LIMS, Historian) as required by business needs.

• Draft, approve and follow relevant system software SOPs and policies.

• Train end-users on basic system functionality.

• Provide end-user support including troubleshooting problems at the application level and basic hardware troubleshooting (includes working with vendors to resolve issues).

• Initiate, author, review documents such as Change Controls, EOE's, NOE's, DNF's, risk assessments, impact statements and corrective/prevention action plans. Participate/lead/author investigations and root cause analysis for department issues of non-compliance.

• Administer user access - Control access to software systems; add, modify and remove users; define user types, user groups and security settings.

• May supervise automation contractors.

Knowledge and Skills:

• Working knowledge of process control systems and product release testing systems preferred.

• Current knowledge of cGMP biotech/pharma operations, regulatory and quality policies, procedures and documentation methods.

• Strong knowledge of System Design Lifecycle and Quality Risk Management

• Must work independently and have project management capabilities.

• Knowledge of biotech/pharma manufacturing process/supporting laboratory testing and 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.

• Strong leadership capabilities and organizational skills.

• Ability to speak to large groups of people (including senior management and regulatory agencies).

• Excellent writing, communication and interpersonal skills.

• Working knowledge of word processing, spreadsheet, PowerPoint and database management software.

Education and Experience:

BS/BA in Science/Engineering or related field preferred along with 2 years of relevant experience in manufacturing/lab/IT setting; will consider minimum 5 years of relevant experience in manufacturing/lab/IT setting in lieu of educational requirement.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.