Process Engineer II
Process Engineer II
Posted on :
13-10-2024
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Job Description
Position Process Engineer
Location Parsippany NJ 07054 (Hybrid)
Duration 12 months
Shift 84:30 8:305 95:30 type of hours (most of team works 95)
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 indepth 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.
Employment Type
Full Time
Key Skills
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