Validation Engineer

2 months ago


New York, New York, United States ATR International Full time
Job Description:

We are seeking a highly skilled Validation Engineer - II to join our team at ATR International. As a key member of our organization, you will play a critical role in ensuring the quality and integrity of our biologics products.

Responsibilities:
  • Develop and Implement CPV Strategies: Apply established commercial biologics Continued Process Verification (CPV) program strategies and contribute to CPV program of one or multiple biologics products.
  • Statistical Analysis and Data Management: 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.
  • Process Improvement: Identify and implement improvements for data collection and management to enable quick and reliable data analysis.
  • Global Process Monitoring: Provide statistical expertise for all global commercial process monitoring in compliance with current ICH / Health Authority, QbD guidelines and SOPs.
  • Investigation Support: Assist in resolution of investigations doing statistical analysis.
  • Complex Problem-Solving: Work on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
Requirements:
  • Technical Expertise: Experience with optimization and statistical data analysis tools such as Minitab, JMP, Spotfire, and R. Basic programming in R and Python preferred.
  • Excellent Communication Skills: Excellent technical writing skill, working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing preferred.
  • Problem-Solving Skills: Excellent troubleshooting skills and ability to solve complex technical issues.
  • Industry Knowledge: Understanding of guidelines required by FDA, EMA, and other regulatory bodies. Extensive knowledge of industry practices.
  • Interpersonal Skills: Excellent verbal, written, and interpersonal communication skills required. Ability to effectively manage multiple projects/priorities.

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