CPV Engineer - ACL Digital

Job Title: Process Monitoring and Data Analytics / Validation Engineer - II

Location: Parsippany, NJ (Hybrid)

Duration: 12+ Months

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)

Job Description

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, 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.