Engineering Specialist Job at TriOptus LLC, Millburn, NJ

  • TriOptus LLC
  • Millburn, NJ

Job Description

Job Description:


Position Requirements:


Education:
• Bachelor's degree in Mechanical Engineering or Electrical Engineering is mandatory.

Experience:
• 3-5 years of relevant experience preferred.
• Candidates with more than 10 years of experience will not be considered.
• Prior experience in the pharmaceutical industry is mandatory. Medical Device industry experience is also acceptable.
• GMP (Good Manufacturing Practices) experience is required.

Key Responsibilities:
• Provide assembly-related input and technical support to the team.
• Perform commissioning and requalification activities.
• Conduct hands-on investigations.
• Write, document, and complete deviation reports.
• Support basic Computer System Validation (CSV) activities.

Required Skills & Tools:
• Experience with CSV and commissioning activities.
• Strong knowledge of deviation investigation and documentation.
• Experience working with QUM (Quality Management System), if applicable.
• Experience using Kneat is preferred.

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