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Validation Engineer

1 month ago

ParsippanyTroy Hills, United States Infotree Global Solutions Full time

Note- On w2 only

Responsibilities:

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.

• 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.


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.


Education and Work Experience Requirements

4+ years of relevant experience and a BS degree in a relevant scientific discipline.

2+ years of relevant experience and an MS degree in a relevant scientific discipline.