Senior Process Engineer, Pharma Development

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Paid holidays

Vacation & sick days

Job summary

Merck in Rahway, NJ, seeks a Senior Engineer to advance pharmaceutical process development for small-molecule solid dosage drugs from pilot to commercial scale. You will partner with R&D, analytical, regulatory, quality, and operations across internal sites and contract manufacturers worldwide.

The role focuses on scale-up, tech transfer and DOE-driven process development, with hands-on lab and manufacturing responsibilities.

Qualifications

• Bachelor’s degree with 6+ years related experience, or Master’s with 4+ years, or PhD in Chemical/Biochemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or related discipline.
• Proven ability to work both independently and as part of a team and execute against commitments.
• Experience with process scale-up and/or technology transfer, moving between laboratory, pilot, and commercial scale.
• Hands-on experience in a laboratory, pilot plant, or manufacturing facility.

Responsibilities

• Plan, conduct, and interpret pharmaceutical process development studies, such as scale up, technology transfer, design space development, clinical and stability batch manufacture, and process validation.
• Participate in or lead drug product working groups and technology development teams and represent the department in cross-functional interactions.
• Apply problem-solving skills and aspects of Quality by Design, including risk-based approaches to development, design of experiments, and process modeling.
• Author technical documents, such as experimental protocols, reports, and regulatory filings.
• Demonstrate oral and written communication skills and effective collaboration and leadership within teams, including commercial sites and/or third-party vendors.
• Evaluate new and innovative technologies and equipment, perform physical testing and data analysis, and comply with applicable safety and current good manufacturing practices.
• Contribute to publications and presentations within the scientific community as appropriate.
• Advance innovation and digital and data analytics capabilities.

Skills

cGMP Regulations

Chemical Engineering

Chemistry

Design of Experiments (DOE)

GMP

Process Development

Process Scale Up

Process Transfers

Technology Transfer

Chromatographic Techniques

Scientific Writing

Scientific Presentations

Small Molecule Synthesis

Strategic Planning

Technical Evaluation

Technical Reviews

Writing Technical Documents

Education

Bachelor’s degree in Chemical/Biochemical Engineering, Materials Science/Engineering, Pharmaceutical Sciences, or related discipline

Job description

Merck in Rahway, NJ, seeks a Senior Engineer to advance pharmaceutical process development for small-molecule solid dosage drugs from pilot to commercial scale. You will partner with R&D, analytical, regulatory, quality, and operations across internal sites and contract manufacturers worldwide.

The role focuses on scale-up, tech transfer and DOE-driven process development, with hands-on lab and manufacturing responsibilities.