New · posted Oct 14
Regeneron · Biotechnology
Process Controls and Validation Engineer
- Rensselaer, NY
- On-site
- Full-time
- Associate & Specialist
Open until filled
The role
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.
What you need
3 ways to qualify
Bachelor’s
+ 0–2 years of experience
Assoc Engineer: BS/BA in Engineering with 0-2+ years industry experience, or equivalent combination of education and experience.
- or
Bachelor’s
+ 2+ years of experience
Engineer: BS/BA in Engineering with 2+ years industry experience; or equivalent combination of education and experience.
- or
Bachelor’s
+ 5+ years of 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.
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. If you have any questions, please speak with your recruiter.
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.
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.
Pay and benefits
$62,355 – $92,400 a year
Employer provided$62,355.00 - $92,400.00
Annual bonuses
Equity awards
401(k) company match
Health and wellness programs
Medical, dental, vision, life and disability insurance
Paid time off
Where you'll work
Rensselaer, NYOn-siteOpen in Maps (opens in a new tab)
More jobs in Rensselaer, NYEqual opportunity, accessibility and legal noticesRegeneron's statements, word for word
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! 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.
Job intelligence
The context around this role
Live data · October 14, 2026
Salary intelligence
How the pay compares
This role's midpoint is level with the US median for Validation & CQV roles at this level.
This roleEmployer provided
Associate & Specialist roles in the US15 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $62,355 | — | $92,400 |
| All US (middle half) | $76,000 | $77,000 | $88,000 |
This role: Regeneron's own published range. Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, October 14, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 88 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not Regeneron's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Validation and qualification6
- Lab testing and methods2
- Documentation and SOPs2
- GMP and compliance1
- Regulatory submissions1
- Collaboration and leadership1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Regeneron on Regulatory Jobs
- 49
- Open roles
- 44
- Distinct roles
- 9
- Locations
By discipline
- Quality33 67%
- Regulatory13 27%
- Compliance & Safety3 6%
By level
- Associate & Specialist24 49%
- Manager13 27%
- Director7 14%
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Process Controls and Validation Engineer at Regeneron
Open until filled. $62K–$92K a year, employer provided.