Senior Project Engineer, CMO Support

Regeneron Pharmaceuticals, Inc (USA); United States; On-site; USD 88,000 - 144,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Troy, NY, is seeking an experienced Project Engineer to support its engineering team and the CMO network.

You will design, specify, and commission biopharmaceutical process and clean utility equipment, renovate systems, and provide technical support at contract manufacturing facilities. This on-site role requires a BS in Chemical/Biochemical Engineering, 5+ years of project/process engineering experience, and knowledge of process controls and cGMP.

Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, or a related field.
• 5+ years of experience in project/process engineering.
• Direct experience with biopharmaceutical process equipment preferred.
• Solid understanding of process control systems and automation.
• Experience planning and tracking project activities and schedules.

Responsibilities

• 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

Skills

Process equipment design

Project management

Cross-functional collaboration

cGMP knowledge

Automation basics

Education

Bachelor's degree in Chemical/Biochemical Engineering

Job description

Build our future together: 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. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

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

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.

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.

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) $88,300.00 - $143,900.00

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
• 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.

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for over 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to nine FDA-approved treatments and numerous product candidates in development, almost all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurology, infectious diseases and rare diseases. Regeneron is also proud of award winning culture of innovation, being recognized as a Great Place to Work in 2021, Fast Company’s Best Workplace for Innovators in 2020, and Forbes JUST companies in 2020, among others.