Validation Engineer

7 days ago


New York, New York, United States ATR International Full time

Job Title: Validation Engineer - II

Job Summary:

We are seeking a highly skilled Validation Engineer - II to join our team at ATR International. As a key member of our team, you will be responsible for applying established commercial biologics Continued Process Verification (CPV) program strategies and contributing to the CPV program of one or multiple biologics products.

Responsibilities:

  • Apply established commercial biologics CPV program strategies and contribute to CPV program of one or multiple biologics products.
  • Author, review, and approve CPV protocols, reports, and present CPV data as needed to Subject Matter Experts (SMEs).
  • Support batch processing data collection and verification activities.
  • Identify and implement improvements for data collection and management to enable quick and reliable data analysis.
  • Provide statistical expertise for all global commercial process monitoring in compliance with current ICH / Health Authority, QbD guidelines, and SOPs.
  • Assist in resolution of investigations doing statistical analysis.

Requirements:

  • Strong background in statistics, process monitoring, and advanced statistical data analysis.
  • Experience with optimization and statistical data analysis tools such as Minitab, JMP, Spotfire, and R.
  • Excellent technical writing skills.
  • Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing.
  • Excellent troubleshooting skills and ability to solve complex technical issues.
  • Understanding of guidelines required by FDA, EMA, and other regulatory bodies.
  • Extensive knowledge of industry practices.
  • Excellent verbal, written, and interpersonal communication skills.
  • Ability to effectively manage multiple projects/priorities.

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