Validation Engineer

Job Title - Validation Engineer

Location - Parsippany, NJ

Hybrid - Onsite T/W/Th

Working hours: 8-4:30, 8:30-5, 9-5:30 type of hours (most of team works 9-5)

Only W2

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.

Knowledge and Skills

•       Experience with optimization and statistical data analysis tools such as Minitab, JMP, Spitfire 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.

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.

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.