Sterile Manufacturing Engineer - Associate Specialist

Merck; Rahway (NJ); On-site; USD 72,000 - 113,000; Full time

Benefits offered by this job

Medical, dental, vision benefits

401(k) retirement plan

Paid holidays and vacation

Job summary

Merck in Rahway, NJ is expanding its Formulation, Laboratory, and Experimentation Sterile 2 facility. The role supports aseptic formulation, filling, lyophilization, and related operations, ensuring regulatory readiness and high-quality clinical supplies.

You'll collaborate with formulators, engineers, and Quality representatives, contributing to deviations, CAPAs, and process improvements while maintaining aseptic practices and GMP compliance.

Qualifications

• Bachelor's degree in engineering or related technical discipline.
• Candidates must be currently pursuing an eligible degree and preparing to graduate by July 2027.
• Available to start by July 2027.
• Knowledge of GMP principles and safety requirements.
• Strong problem-solving and organizational skills.

Responsibilities

• Provide technical support for formulation, process development, scale-up, and technology transfer activities.
• Draft and maintain investigations, change controls, SOPs, batch documentation, and technical protocols.
• Support commissioning, qualification, and regulatory readiness activities for the sterile clinical manufacturing facility.
• Assist with data review, technical assessments, troubleshooting, and continuous improvement activities.
• Develop end-to-end understanding of manufacturing operations and manage daily floor activities.

Skills

Aseptic Handling

Clinical Manufacturing

Driving Continuous Improvement

Engineering Standards

Equipment Qualification

GMP Compliance

Manufacturing Systems

Operations Support

Process Improvements

Technical Support

Education

Bachelor’s degree in engineering or related field

Tools

SAP

HMI Systems

Calibration & Maintenance Databases

Microsoft Office

Job description

Merck in Rahway, NJ is expanding its Formulation, Laboratory, and Experimentation Sterile 2 facility. The role supports aseptic formulation, filling, lyophilization, and related operations, ensuring regulatory readiness and high-quality clinical supplies.

You'll collaborate with formulators, engineers, and Quality representatives, contributing to deviations, CAPAs, and process improvements while maintaining aseptic practices and GMP compliance.