Validation/Process Monitoring Engineer

2 months ago

parsippany, United States Planet Pharma Full time

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.

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