Process Engineer II

Responsibilities:
Process Engineer/Validation Engineer having strong background in statistics process monitoring and advanced statistical data analysis
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 moderatel y complex problems where analysis of situations or data requires an indepth 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 Spotfire and R.
Basic programming in R and Python
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.