Senior Process Development & Technology Engineer (Device Assembly)

Regeneron Pharmaceuticals, Inc.; United States; On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Annual bonuses

Equity awards

401(k)

Health benefits

Paid time off

Family support

Job summary

Regeneron Pharmaceuticals, Inc. is seeking an experienced engineer to guide process development and scale-up for GMP assembly of combination products such as prefilled syringes and auto-injectors.

You will translate the QTPP into CQAs, develop risk-based plans for characterization, and establish CPPs while building a robust control strategy per ICH Q8-Q11 and Q9. You will plan end-to-end DoE-driven characterization, perform statistical analyses to define operating ranges, and collaborate on

Qualifications

• BA/BS in Engineering field is required; 2+ years proven experience for Engineer level.
• Senior Engineer requires 5+ years proven experience in process development or related field.
• Experience with DoE, CPPs, CQAs, and QC processes within GMP environments.

Responsibilities

• Guide process development and scale-up for GMP assembly of combination products.
• Translate QTPP into CQAs and build a control strategy using ICH Q8-Q11 and Q9.
• Plan DoE-based characterization and perform statistical analyses to define operating ranges.
• Collaborate on IPCs, sampling plans, PPQ approaches, and SPC with internal/external partners.
• Support tech transfer, regulatory filings, and change controls with detailed narratives.

Skills

DoE

Statistical analysis

Cross-functional collaboration

GMP knowledge

Quality systems

Education

BS in Engineering

Tools

JMP

Minitab

Job description

Build our future together:

When & where:

Location: East Greenbush, NY

Shift Requirements: Monday-Friday- 8-4:30pm

Travel: 10-20% domestic- sometimes international

Discover your role:

Guide process development and scale-up for GMP assembly of combination products (prefilled syringes, auto injectors, on-body injectors)

Translate the Quality Target Product Profile (QTPP) into Critical Quality Attributes (CQAs), make risk-based plans for characterization experiments, identify Critical Process Parameters (CPPs), and build a control strategy using ICH Q8-Q11 and Q9 principles

Plan and implement end-to-end process characterization using Design of Experiments (DoE), statistical analysis, and engineering studies to define operating ranges and limits

Collaborate on development and implementation of in-process controls (IPCs), sampling plans, PPQ approaches, and SPC monitoring with internal and external partner groups

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

Highly preferred qualifications:

A background in aseptic processing, drug substance development, drug product development, or biopharmaceutical/combination product validation

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

Knowledge of sterilization modalities and implications for materials and packaging (e.g., EtO, gamma, e-beam)

Experience working with CMOs/CDMOs and delivering tech transfers across sites

Knowledge of QbD and ICH Q8-Q11, Q9 methodologies to define CQAs, CPPs, CMAs, risk assessments (FMEA), and control strategies

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)

Hands-on experience with equipment URS, FAT/SAT, IQ/OQ/PQ, PPQ, and CPV

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
• family support benefits

For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewa