Process Engineer from Collabera

Job Description:

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 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, 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.

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.