Associate Specialist, Engineering (Onsite) Job at Merck, Rahway, NJ

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  • Merck
  • Rahway, NJ

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

Job Tags

Work at office, Flexible hours

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