Assoc Automation Systems Administrator

Summary: Responsible for administration of automated/computerized system software and firmware to meet cGMP and procedural requirements. Documents COTS software configuration for biopharmaceutical process, monitoring, and testing systems. Executes 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 per procedure.

• Documents system configurations for cGMP software for process control, monitoring and testing.

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

• Supports review of system lifecycle design documentation

• Process change control requests for system configurations, including requirement and/or design specifications, test plans, technical evaluation and quality risk assessments.

• Follow relevant system software SOPs and policies.

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

• Support Change Controls, NOE's, risk assessments, impact statements and corrective/prevention action plans. Assist with 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 per procedure.

Education and Experience:

BS/BA in Science/Engineering or related field preferred along with 1-2 years of relevant experience in manufacturing/lab/IT setting; will consider minimum 3 years of relevant experience in manufacturing/lab/IT setting in lieu of educational requirement.

Knowledge Skills, and Abilities:

• 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.

• Knowledge of Risk Assessments

• Must work independently and have project team member 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.

• Excellent writing, communication and interpersonal skills.

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

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)