Massachusetts Veterans Jobs

Regeneron Cell Medicines (RCM) is a newly formed research & development (R&D) unit within Regeneron to advance cell therapies and combination approaches in oncology and immunology.

This role will support and maintain Building Management, Clinical Manufacturing Equipment and data acquisition and monitoring systems that support Clinical Manufacturing and R&D.

The successful candidate for this role is one that enjoys spending most of their time as the Technical SME but is also capable and enjoys operating at the system administration, engineering and management level.

In this role typical day might include the following:

• IT Applications Analyst responsibilities, supporting all Manufacturing and QC Equipment within RCM’s 30,000 SF Phase 1 Clinical Manufacturing Facility

• Coordinates across business departments and stakeholders, gathering and implementing enhancement requests across departments

• Acts as a Technical SME/Lead on initiatives

• Responsible for System documentation, including, converting User Requirement Specifications to a Detail Design Specification, writing Configuration Test Plans and summary reports.

• Leads IT Applications systems security access and periodic audit trail reviews

• Automation Engineering responsibilities, as required to support ongoing operations and minor modifications/projects.

• Provide technical automation support and troubleshooting to Manufacturing, Quality Control, and Facilities according to established SOPs and departmental practices

• Perform investigations relating to manufacturing deviations and anomalies associated with automation systems and control system software

• Develop and edit engineering design documents, technical evaluations, and test plans for cGMP process equipment and follow GAMP 5 guidelines as they relate to assigned projects

• Support engineering and validation projects as well as provide support to manufacturing activities with process control and process monitoring equipment software design, commissioning, and testing to meet end user requirements

• Support automation activities by updating or authoring system specifications, user and functional requirements specifications, generating and executing necessary FAT and SAT protocols

• Support small manufacturing process control projects related to corrective action, equipment performance improvement, and new equipment

• Design, develop, and implement software/hardware improvements to automated process control and process monitoring equipment according to change control procedures

• Develop and execute test plans for software/hardware improvements to automated process control and process monitoring equipment according to change control procedures

• Systems Administrator for Facilities Owned Systems responsibilities:

• 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.

• 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.

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

This job might be for you if you have the following:

• B.S. or B.A. degree in Information Technology or related field and minimum 5 years of relevant experience preferred or equivalent combination of education and experience

• A minimum 5 years of relevant experience in manufacturing/lab/IT setting in lieu of educational requirement

• Experience in a pharmaceutical or biopharmaceutical manufacturing facility

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$79,100.00 - $129,100.00