Technology Transfer Engineer

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. Regeneron is currently looking for a Process Controls & Validation Engineer to join our Process Sciences Drug Product Engineering department. This technical services department handles a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. The Process Controls and Validation Engineer provide technical support to manufacturing, quality, chemistry manufacturing compliance regulatory for manufacturing processes from technology transfer and/or design transfer to post-commercial lifecycle management activities.

 

When & where:

• Location: Rensselaer, New York, United States
• Work model: Monday-Friday, 8am-4:30pm
• Travel percentage: 10% domestic & occasionally international

 

Discover your role:

• Evaluates product and process risks during technology transfer, design transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities
• Analyzes information and data from development through late stage-characterization as well as at-scale manufacturing history
• Authors protocols, reports, and/or other technical documents with conclusions based on all available process and product knowledge
• Ensures alignment of standard operating procedures, policies, validation plans, and other internal documentation with industry and regulatory expectations such as ICH guidelines
• Provides support to audits/inspections and drafting of chemistry manufacturing compliance sections of regulatory submission as needed
• Analyzes data using a combination of statistics, engineering principles and other techniques to gain insight into manufacturing process performance and control
• Provides support for laboratory studies and/or at-scale studies performed to support process characterization and validation activities

 

This role requires:

• BS in bioengineering, chemical engineering, or related engineering field
  • Associate Process Controls & Validation Engineer: 0-2 years of experience
  • Process Controls & Validation Engineer: 2 + years of experience
  • Level will be determined based on experience
• A background in aseptic processing, drug substance development, drug product development, combination product development or biopharmaceutical/combination product validation is preferred

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)

$62,355.00 - $110,000.00