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Senior Project Engineer, CMO Support

Regeneron Pharmaceuticals

Troy, NYOnsitePosted 52 days ago$88,300 - $143,900/year
Full TimeSenior LevelManufacturing & CMCBiotechnology
Original posting ↗

Summary

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking an experienced Project Engineer to join our growing Engineering team, supporting our Contract Manufacturing Organization (CMO) network. In this role, you will design, specify, and commission new biopharmaceutical process and clean utility equipment, renovate existing systems, and provide engineering support for equipment installed at contract manufacturing facilities.

Job description

When & where

  • Location: Troy, New York, United States
  • Work model: On-site Monday-Friday 8:00am-4:30pm
  • Travel percentage: up to 25%, domestic and international

Discover your role

  • Design and specify cGMP process equipment, piping, and/or controls, including development and review of engineering documentation
  • Manage small-to-mid sized projects related to process equipment and clean utilities, including start-up and commissioning
  • Assist in and lead the design review, site acceptance, and installation of equipment
  • Prepare piping and instrumentation diagrams and other related drawings, and develop Process Flow Diagrams for manufacturing processes
  • Support QA/Validation department by preparing design documents and assisting in protocol execution
  • Investigate process equipment, utility system, and control system anomalies, as well as safety incidents, implementing corrective and preventive actions
  • Prepare and execute change controls, including engineering evaluation and test plan documentation
  • Supervise mechanical, electrical, and automation contractors
  • Procure equipment and equipment-related services, including negotiating with suppliers
  • Provide engineering support for equipment installed at contract manufacturing facilities

This role requires

  • Bachelor's degree in Chemical Engineering, Biochemical Engineering, or another relevant Engineering discipline
  • 5+ years of experience in project/process engineering, or an equivalent combination of education and experience
  • Direct experience with biopharmaceutical process equipment is preferred
  • Solid understanding of process control systems and automation
  • Thorough knowledge of engineering documentation for cGMP process equipment and sanitary equipment design requirements
  • Experience planning and tracking project activities and schedules
  • Strong interpersonal and cross-cultural communication skills, with the ability to lead without direct authority
  • Gowning and Physical Requirements:
  • Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)
  • Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

Requirements

  • Bachelor's degree in Chemical Engineering, Biochemical Engineering, or another relevant Engineering discipline
  • 5+ years of experience in project/process engineering, or an equivalent combination of education and experience
  • Direct experience with biopharmaceutical process equipment is preferred
  • Solid understanding of process control systems and automation
  • Thorough knowledge of engineering documentation for cGMP process equipment and sanitary equipment design requirements
  • Experience planning and tracking project activities and schedules
  • Strong interpersonal and cross-cultural communication skills, with the ability to lead without direct authority
  • Full cleanroom attire
  • Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

Benefits

  • Annual bonuses
  • Incentive plans
  • Equity awards
  • Pension or retirement benefits
  • 401(k) company match
  • Health and wellness programs
  • Fitness centers
  • Insurance benefits
  • Paid time off
  • Family support benefits

Company overview

Regeneron Pharmaceuticals is a leading American biotechnology company founded in 1988 and headquartered in Tarrytown, New York. The company specializes in inventing, developing, and commercializing life-transforming medicines for people with serious diseases. Regeneron is renowned for its innovative antibody technologies and has developed several groundbreaking therapies, including EYLEA® for retinal diseases, DUPIXENT® for inflammatory conditions, and the COVID-19 antibody cocktail REGEN-COV®. The company operates with a strong focus on research and development across multiple therapeutic areas including ophthalmology, oncology, cardiovascular diseases, and rare genetic disorders. Regeneron's proprietary VelocImmune® technology platform enables the rapid generation of fully human monoclonal antibodies. With over 15,000 employees globally and annual revenues exceeding $14 billion, Regeneron has established itself as a major force in the biotechnology industry, consistently ranking among the top-performing pharmaceutical companies and maintaining a robust pipeline of investigational therapies.

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