Sr. Process Controls & Validation Engineer

Regeneron Pharmaceuticals • Valley, AL

2d • Onsite

About The Position

Regeneron is currently looking for a Sr. Process Controls and Validation Engineer to join the Drug Product Process Sciences team. In this non-lab based role, you will serve as a technical driver for the at-scale process development and technology transfer of drug product manufacturing processes — from clinical tech transfer through process validation and commercial lifecycle management — across Regeneron's global CMO network. A typical day for a Sr. Process Controls and Validation Engineer might include: Developing and applying DP development tools to generate product-specific process recommendations that support clinical and commercial tech transfer across Regeneron's global CMO network Establishing DP platform manufacturing processes for clinical manufacturing application across freeze/thaw, mixing, filtration, filling, and lyophilization unit operations Designing and qualifying small-scale laboratory models to generate data supporting process qualification execution Coordinating the development strategy for drug product tech transfers using risk-based tools in alignment with ICH Quality by Design (QbD) principles and regulatory expectations Collaborating with cross-functional partners including modeling, technology transfer, formulation, and filling site counterparts to guide study designs, review and approve protocols and reports, and ensure on-time delivery Analyzing product and process data using statistics, engineering principles, and risk-based decision-making to evaluate Critical to Quality Attributes (CQAs) and Critical Process Parameters (CPPs) across the product lifecycle Supporting audit readiness and contributing to CMC sections of regulatory submissions This role might be for you if you: Have a strong working knowledge of ICH guidelines, QbD principles, and risk-based approaches to drug product process development and validation Enjoy building structure in ambiguous spaces — whether that's developing a new predictive tool, establishing a qualified model framework, or creating documentation that didn't previously exist Are energized by cross-functional collaboration and can translate complex technical concepts clearly for partners across development, manufacturing, quality, and regulatory Are eager to contribute to a team that is actively redefining how drug product tech transfer is done at Regeneron at a fast pace Are willing to travel up to 10% annually to support CMO engagements and development activities To be considered for this role, you must be willing and able to work Monday–Friday, 8am–4:30pm. You must have a B.S. in Engineering; chemical engineering, biochemical engineering, or a related field is preferred. For various levels you must have the following: Process Controls and Validation Engineer: 2+ years Sr. Process Controls and Validation Engineer: 5+ years A background in aseptic processing, drug product development, or biopharmaceutical process validation is strongly preferred. Level is determined based on qualifications relevant to the role. Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries’ specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location. 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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $67,400.00 - $128,700.00 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.

Requirements

• Have a strong working knowledge of ICH guidelines, QbD principles, and risk-based approaches to drug product process development and validation
• Enjoy building structure in ambiguous spaces — whether that's developing a new predictive tool, establishing a qualified model framework, or creating documentation that didn't previously exist
• Are energized by cross-functional collaboration and can translate complex technical concepts clearly for partners across development, manufacturing, quality, and regulatory
• Are eager to contribute to a team that is actively redefining how drug product tech transfer is done at Regeneron at a fast pace
• Are willing to travel up to 10% annually to support CMO engagements and development activities
• To be considered for this role, you must be willing and able to work Monday–Friday, 8am–4:30pm
• B.S. in Engineering; chemical engineering, biochemical engineering, or a related field is preferred
• Sr. Process Controls and Validation Engineer: 5+ years

Nice To Haves

• A background in aseptic processing, drug product development, or biopharmaceutical process validation is strongly preferred.

Responsibilities

• Developing and applying DP development tools to generate product-specific process recommendations that support clinical and commercial tech transfer across Regeneron's global CMO network
• Establishing DP platform manufacturing processes for clinical manufacturing application across freeze/thaw, mixing, filtration, filling, and lyophilization unit operations
• Designing and qualifying small-scale laboratory models to generate data supporting process qualification execution
• Coordinating the development strategy for drug product tech transfers using risk-based tools in alignment with ICH Quality by Design (QbD) principles and regulatory expectations
• Collaborating with cross-functional partners including modeling, technology transfer, formulation, and filling site counterparts to guide study designs, review and approve protocols and reports, and ensure on-time delivery
• Analyzing product and process data using statistics, engineering principles, and risk-based decision-making to evaluate Critical to Quality Attributes (CQAs) and Critical Process Parameters (CPPs) across the product lifecycle
• Supporting audit readiness and contributing to CMC sections of regulatory submissions

Benefits

• health and wellness programs (including medical, dental, vision, life, and disability insurance)
• fitness centers
• 401(k) company match
• family support benefits
• equity awards
• annual bonuses
• paid time off
• paid leaves (e.g., military and parental leave)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 5,001-10,000 employees