Senior Project Engineer, CMO Support

BioSpace; City of Troy (NY); On-site; USD 88,000 - 144,000; Full time

Job summary

Regeneron is seeking an experienced Project Engineer to join our Engineering team, supporting our Contract Manufacturing Organization network. You will design, specify, and commission biopharmaceutical process equipment, renovate systems, and provide engineering support at CMOs to keep pace with fast-growing bioscience programs.

Location is Troy, New York with on-site work schedule Mon-Fri. Candidates should have 5+ years in project/process engineering, strong knowledge of process controls, and

Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, or another relevant Engineering discipline.
• 5+ years of experience in project/process engineering or equivalent.
• Direct experience with biopharmaceutical process equipment 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 for cleanroom attire.

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 by preparing design documents and assisting in protocol execution.
• Investigate process equipment, utility system, and control system anomalies, and implement corrective actions.
• Prepare and execute change controls, including engineering evaluation and test plan documentation.
• Supervise mechanical, electrical, and automation contractors.
• Procure equipment and related services, including negotiating with suppliers.
• Provide engineering support for equipment installed at contract manufacturing facilities.

Skills

Project management

Cross-functional work

Process control systems

Automation knowledge

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.

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. 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 onsite. Please speak with your recruiter and hiring manager for more information about onsite 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)

$88,300.00 - $143,900.00