Validation Engineer - II

We are seeking a Validation Engineer - II for a very important client. Responsibilities: • Strong background in statistics, process monitoring and advanced statistical data analysis. • Apply established commercial biologics Continued Process Verification (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. • Identifies and implements improvements for data collection and management to enable quick and reliable data analysis. • Provides 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. • Works on moderately complex problems where analysis of situations or data requires an in-depth evaluation of various factors. • Exercises judgment within generally defined practices and policies in selecting statistical methods, techniques and evaluation criteria for obtaining results. Requirement: Knowledge and Skills • Experience with optimization and statistical data analysis tools such as Minitab, JMP, Spotfire and R Basic programming in R and Python preferred • Excellent technical writing skill • Working knowledge of GMP and regulatory requirements of biopharmaceutical manufacturing is preferred • 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 are required. • Ability to effectively manage multiple projects/priorities. Must Have: • Strong background in statistics, process monitoring and advanced statistical data analysis. • Apply established commercial biologics Continued Process Verification (CPV) program strategies and contribute to CPV program of one or multiple biologics products. • Support batch processing data collection and verification activities.

Created: 2024-11-19