Sr. Process Characterization Engineer

Regeneron is currently looking for a Process Characterization & Technology Engineer to join our process development team within the Process Sciences Drug Product Engineering department. This role is responsible for characterization of manufacturing operations and/or technology through prospectively defined laboratory experiments. Process Characterization and Technology Engineers may support all phases of projects from research and feasibility studies through implementation into commercial manufacturing processes.

As a Process Characterization & Technology Engineer , a typical day might include the following:

• Generate validation plans and validation plan appendices.

• Generate and oversee the execution of process validation protocols for process performance qualification and associated studies.

• Analyze protocol derived data using statistical methods and generate process validation summary reports.

• Analyze routine process data using statistical methods and author technical reports.

• May provide on-the-floor support during protocol execution by manufacturing, as required.

• Present data from validation studies as required.

• Support technology transfer activities including approval of manufacturing documentation and procedures, where required.

• Participates in process and quality risk assessments, including process failure mode and effects analysis.

• Communicate information on current process data and other IOPS initiatives which may impact process development, process control strategy, and/or technology transfer.

• Apply statistical process control tools in monitoring the manufacturing process.

• Assist in troubleshooting and continuous improvement activities associated with the manufacturing process.

• Serve as functional area subject matter expert in regulatory inspections.

• May manage projects related to process validation and continuous improvement initiatives.

This role might be for you if

• You are a problem-solver, are willing to take action, self-starter.

• You show eagerness to apply expertise in diagnosing inefficiencies, resolving root causes, and recommending solutions to challenges.

• If you want to be a part of a fun, dynamic, challenging, and inclusive environment.

• You can quickly learn complex processes and write technical documentation.

• You have demonstrated experience and knowledge in the following areas:

• Combination device assembly, packaging, and labeling production operations

• Transfer and/or development of regulated medical devices, combination products, or drug products

• Regulatory and industry standards such as 21 CFR 4, 21 CFR 210, 21 CFR 211, 21 CFR 820, ISO 13485 and ISO 14971

• Equipment and process validation best practices, i.e. IQ, OQ, PQ, PPQ.

• Industry practices (cGMP, Annex I) across multiple health authorities (e.g. FDA, EMA, MHRA, etc.)

• Study design and statistical analysis methods

• Root cause analysis tools and methods

To be considered for Process Characterization & Technology Engineer you must be willing and able to work Monday-Friday, 8am-4:30pm. You must have a B.S in Engineering; Biomedical Engineering, Chemical Engineering or Mechanical Engineering is preferred. For various levels you must have the following:

• Process Characterization & Technology Engineer: 2+ years of relevant experience

• Sr. Process Characterization & Technology Engineer: 5+ years of relevant experience

Level is determined based on qualifications relevant to the role.

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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)

$65,100.00 - $124,300.00