Validation Specialist

2 days ago


East Greenbush, New York, United States Intellectt Inc Full time
Job Title: Validation Engineer

At Intellectt Inc, we are seeking a highly skilled Validation Engineer to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the accuracy and reliability of our packaging and assembly equipment.

Responsibilities:

  • Develop and execute validation protocols for packaging and assembly equipment, including Seidenader, Bausch+Strobel, Harro Hofliger, Fargo, Dividella, and Pester systems.
  • Collaborate with cross-functional teams to assess and improve validation processes and documentation.
  • Prepare comprehensive validation reports and documentation in accordance with regulatory requirements.
  • Review and approve equipment change controls, deviations, and CAPAs.
  • Provide technical support and guidance during equipment installations and upgrades.
  • Ensure compliance with cGMP and industry regulations throughout the validation process.
  • Train and mentor team members on validation best practices and procedures.

Requirements:

  • Bachelor's degree in Engineering, Life Sciences, or a related field.
  • 3+ years of experience in validation within the pharmaceutical, biotech, or medical device industries.
  • Strong experience with packaging and assembly equipment, particularly Seidenader, Bausch+Strobel, Harro Hofliger, Fargo, Dividella, and Pester machines.
  • Familiarity with validation processes, documentation, and regulatory requirements.
  • Excellent analytical and problem-solving skills.
  • Strong communication and interpersonal skills.


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