Process Engineer II - Katalyst Healthcares & Life Sciences

• 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.

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.