Senior Process Engineer - Pharmaceutical PD Hybrid

Merck & Co.; Rahway (NJ); Hybrid; USD 117,000 - 184,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) plan

Paid time off

Job summary

Merck & Co., Inc. seeks a Senior Engineer in Rahway, NJ to drive pharmaceutical process development for solid dosage products, from scale-up to validation and beyond.

The role emphasizes design-space development, technology transfer, and collaboration with internal and external partners. The candidate will apply DOE, rugged experimentation, and statistical methods within a cGMP framework, contributing to product commercialization and regulatory filings.

Qualifications

• Bachelor's degree with 6+ years experience or Master's/PhD with related experience.
• Experience designing and executing experimental programs with mechanistic understanding.
• Experience with process scale-up and technology transfer between lab, pilot, and commercial scale.

Responsibilities

• Plan, conduct, and interpret pharmaceutical process development studies (scale up, tech transfer, design space, batch manufacture, process validation).
• Lead drug product working groups and cross-functional teams; represent department.
• Apply problem‑solving and Quality by Design approaches; use risk-based development and process modeling.
• Author technical documents including experimental protocols, reports, and regulatory filings.
• Demonstrate strong communication and collaboration with sites and third‑party vendors.

Skills

cGMP Regulations

Chemical Engineering

Chemistry

DOE (Design of Experiments)

Process Development

Process Scale Up

Process Transfers

Scientific Writing

Education

Bachelor's degree in Chemical/Biochemical Eng, Materials Science/Engineering, Pharmaceutical Sciences or related

6 years related experience

Master's degree +4 years related experience

PhD (no additional experience required)

Tools

GxP Documentation Tools

Job description

Merck & Co., Inc. seeks a Senior Engineer in Rahway, NJ to drive pharmaceutical process development for solid dosage products, from scale-up to validation and beyond.

The role emphasizes design-space development, technology transfer, and collaboration with internal and external partners. The candidate will apply DOE, rugged experimentation, and statistical methods within a cGMP framework, contributing to product commercialization and regulatory filings.