Contribute to qualification of equipment and tooling, URS/FRS/FAT/SAT and IQ/OQ/PQ
Support packaging and labeling processes, print/vision inspection, serialization, tamper evidence, and transport and distribution simulation where applicable.
Author and maintain reports, SOPs, work instructions, and electronic records; ensure compliant change control, deviation investigations, and CAPA effectiveness
Coordinate with QA, RA, Device Engineering, CMC, Supply Chain, and external CMOs to enable tech transfer and operational readiness; support regulatory filings with clear process narratives and summaries
This role requires
BA/BS in Engineering related field
Engineer: BS/BA in Engineering with 2+ years proven experience
Sr Engineer: BS/BA in Engineering with 5+ years proven experience
A background in aseptic processing, drug substance development, drug product development, or biopharmaceutical/combination product validation preferred
Experience with auto-injectors, pen injectors, prefilled syringes
Practical knowledge of 21 CFR Parts 4, 210/211, 820; ISO 13485; and ISO 14971 risk management highly preferred
Knowledge of sterilization modalities and implications for materials and packaging (e.g., EtO, gamma, e-beam) is helpful
Experience working with CMOs/CDMOs and delivering tech transfers across sites preferred
Knowledge of QbD and ICH Q8–Q11, Q9 methodologies to define CQAs, CPPs, CMAs, risk assessments (FMEA), and control strategies is helpful
Knowledge of DoE and statistical analysis using tools such as JMP or Minitab; solid understanding of SPC, capability measures, and sampling plans (e.g., AQL) helpful
Hands-on experience with equipment URS, FAT/SAT, IQ/OQ/PQ, PPQ, and CPV preferred
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.
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.
- Salary Range (annually)
- $67,400.00 - $128,700.00
