Process Controls and Validation Engineer

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 110,000 - 140,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a Process Controls and Validation Engineer to provide technical support across technology transfer, process control strategy development, and the lifecycle of process validation from development to post-commercialization.

The role collaborates with Manufacturing, Quality Control, Quality Assurance, and CMC regulatory teams to ensure compliant, robust processes. The ideal candidate has a BS/BA in Engineering with 2+ years of experience for Engineer

Qualifications

• Assoc Engineer: BS/BA in Engineering with 0-2+ years industry experience, or equivalent.
• Engineer: BS/BA in Engineering with 2+ years industry experience; or equivalent combination of education and experience.
• Sr Engineer: BS/BA in Engineering with 5+ years industry experience; or equivalent combination of education and experience.

Responsibilities

• Provides technical support to technology transfer, design transfer, process control strategy development, process validation lifecycle and post-commercialization activities.
• Evaluates product and process risks during technology transfer, design transfer, process control strategy development, process validation lifecycle and post-commercialization activities.
• Analyzes information and data from development through late-stage characterization as well as at-scale manufacturing history.
• Liaises with Manufacturing, Quality Control, Quality Assurance and CMC regulatory to support process lifecycle management.
• Authors protocols, reports, and其它 technical documents with conclusions based on all available process and product knowledge.
• Ensures alignment of SOPs, policies, validation plans, and other internal documentation with industry and regulatory expectations such as ICH guidelines.
• Provides support to audits/inspections and drafting of CMC sections of regulatory submission as needed.
• Applies engineering principles to the development and execution of process controls and validation strategies.
• Analyzes data using statistics and engineering principles to gain insights into manufacturing process performance and control.
• Works effectively in a team-oriented environment.
• Supports laboratory studies and/or studies performed at manufacturing scale.

Skills

Process controls

Process validation

Aseptic processing (preferred)

Education

Assoc Engineer, BS/BA in Engineering

Engineer, BS/BA in Engineering

Sr Engineer, BS/BA in Engineering

Job description

Summary

Process Sciences is a technical services department that deals with a range of scientific, technical, engineering and mathematical needs from the laboratory to the manufacturing floor. Process Controls and Validation Engineer provides technical support to manufacturing, quality and CMC Regulatory for manufacturing processes from technology transfer and/or design transfer to post-commercial lifecycle management activities.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Provides technical support to a variety of activities such as technology transfer, design transfer, process control strategy development, process validation lifecycle and/or post-commercialization activities.
• 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.
• Liaises with other departments including Manufacturing, Quality Control, Quality Assurance and CMC regulatory to support management of the process lifecycle.
• Authors protocols, reports, and/or other technical documents with conclusions based on all available process and product knowledge.
• Ensures alignment of SOPs, policies, validation plans, and other internal documentation with industry and regulatory expectations such as ICH guidelines.
• Provides support to audits/inspections and drafting of CMC sections of regulatory submission as needed.
• Applies engineering principles to the development and execution of process controls and validation strategies.
• Analyzes data using a combination of statistics, engineering principles and other techniques to gain insights into manufacturing process performance and control.
• Works effectively and efficiently in a team-oriented environment.
• Provides support for laboratory studies and/or studies performed at manufacturing scale.

Education and Experience:

• Assoc Engineer: BS/BA in Engineering with 0-2+ years industry experience, or equivalent combination of education and experience.
• Engineer: BS/BA in Engineering with 2+ years industry experience; or equivalent combination of education and experience.
• Sr Engineer: BS/BA in Engineering with 5+ years industry experience; or equivalent combination of education and experience.
• A background in aseptic processing, drug substance development, drug product development, or biopharmaceutical/combination product validation is preferred, but not required.

Does this sound like you?

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.

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.

If you have any questions, please speak with your recruiter.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of