Job Description

Merck's FLEx Sterile 2 facility in Rahway, New Jersey seeks Associate Specialists for Technical Operations or Operations teams. The role involves supporting sterile clinical manufacturing startup, equipment commissioning, regulatory readiness, and GMP-compliant operations across formulation, filling, and lyophilization activities.

Responsibilities

• Provide technical support for formulation, process development, scale-up, and technology transfer activities
• Draft and maintain investigations, change controls, standard operating procedures, and batch documentation
• Support commissioning, qualification, and regulatory readiness for the FLEx Sterile facility
• Execute sterile operations in formulation, filling, lyophilization, and support areas while maintaining GMP compliance
• Contribute to deviation investigations, corrective/preventive actions, and process improvement initiatives

Requirements

• Bachelor's degree in engineering, chemistry, biological sciences, pharmaceutical sciences, or related technical discipline
• Knowledge of GMP principles and safety requirements with ability to apply site procedures
• Strong problem-solving, organizational skills, and ability to manage multiple priorities independently
• Proficiency with Microsoft Office, equipment HMIs, SAP, and maintenance database systems
• Ability to lift 50 pounds, work in Grade C cleanroom, wear respirators, and maintain aseptic practices
• Excellent verbal and written communication skills
• Ability to prepare Standard Operating Procedures and GXP documents

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