Validation/Process Monitoring Engineer & Statistical Data Analyst

Job ID: 615342

Our client, a leading biotech company, is seeking a Validation Engineer with strong statistical analysis skills - see below for other info!

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.

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.

Requirements

3+ 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.