Engineering Specialist

Posted 7 days ago

trioptusMillburn (NJ)

SENIORITY

Senior

About the role

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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