Engineering Associate Specialist - Sterile Drug Ops

Merck & Co.; Rahway (NJ); Vor Ort; USD 72.000 - 113.000; Vollzeit

Zusammenfassung

Merck & Co. in Rahway, NJ, invites applications for a technically focused role in the FLEx Tech Ops/Operations teams. You will support formulation, filling, lyophilization, and aseptic processes, while contributing to qualification, commissioning, and regulatory readiness activities.

A Bachelor's in an engineering or related technical field with GMP exposure is expected, with July 2027 graduation targeted. You will work closely with formulators, engineers, and QA to ensure product quality,

Qualifikationen

• Knowledge of GMP principles and safety requirements.
• Strong problem-solving and organizational skills.
• Ability to communicate and work with others in a manufacturing environment.
• Ability to prepare SOPs and current GXP documents.
• Excellent verbal and written communication skills.
• Proficiency with Microsoft Office, HMIs, SAP, and calibration databases.

Aufgaben

• 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 FLEx Sterile facility.
• Support operation and troubleshooting of aseptic formulation, filling, and lyophilization equipment.
• Manage assigned technical work and contribute to facility, equipment, and process improvements.
• Assist with data review, technical assessments, troubleshooting, and continuous improvement.

Kenntnisse

GMP knowledge

Problem solving

Communication

SOP drafting

Microsoft Office

HMI systems

Calibration databases

Ausbildung

Bachelor's degree in engineering or related technical field

Graduation by July 2027

Tools

SAP

Jobbeschreibung

Merck & Co. in Rahway, NJ, invites applications for a technically focused role in the FLEx Tech Ops/Operations teams. You will support formulation, filling, lyophilization, and aseptic processes, while contributing to qualification, commissioning, and regulatory readiness activities.

A Bachelor's in an engineering or related technical field with GMP exposure is expected, with July 2027 graduation targeted. You will work closely with formulators, engineers, and QA to ensure product quality,