OSD Process Engineer: NPI, Tech Transfer & Validation

Wuxi Apptec, Inc.; Town of Middletown (NY); On-site; USD 90,000 - 150,000; Full time

Job summary

Wuxi AppTec, Inc. in Middletown, NY is seeking a Process Engineer to lead NPI, technology transfers, process validation, and lifecycle management of pharmaceutical manufacturing processes, initially supporting Oral Solid Dosage (OSD) operations.

The role provides technical ownership for assigned products, collaborates with Quality, Manufacturing, Regulatory, and customers, and may expand to sterile manufacturing as site capabilities grow, including CPV programs, PPQ campaigns, and continuous

Qualifications

• Bachelor's degree with 8+ years of pharmaceutical manufacturing experience.
• Master's degree with 6+ years of pharmaceutical manufacturing experience.
• Demonstrated experience leading complex technical projects in a GMP environment.

Responsibilities

• Lead technology transfer and NPI activities for new and existing products.
• Provide technical ownership for assigned products across lifecycle stages.
• Schedule and execute validation activities including PPQ, CPV, and cleaning validation.
• Collaborate with Quality, Manufacturing, Regulatory, and customers to ensure compliant operations.
• Support sterile manufacturing transfers and lifecycle management as site capabilities expand.

Skills

Cross-functional leadership

Troubleshooting

Root cause investigation

Technical writing

Project leadership

Statistical analysis

Communication and presentation

Education

Bachelor's degree in Chemical Engineering or related field

Advanced degree preferred

Job description

Wuxi AppTec, Inc. in Middletown, NY is seeking a Process Engineer to lead NPI, technology transfers, process validation, and lifecycle management of pharmaceutical manufacturing processes, initially supporting Oral Solid Dosage (OSD) operations.

The role provides technical ownership for assigned products, collaborates with Quality, Manufacturing, Regulatory, and customers, and may expand to sterile manufacturing as site capabilities grow, including CPV programs, PPQ campaigns, and continuous