Process Engineer II - Leadstack Inc
Parsippany, NJ 07054
About the Job
LeadStack Inc. is an award-winning, one of the nation's fastest-growing, certified minority-owned (MBE) staffing services provider of contingent workforce. As a recognized industry leader in contingent workforce solutions and Certified as a Great Place to Work, we're proud to partner with some of the most admired Fortune 500 brands in the world.
Job Title: Process Monitoring and Data Analytics
Location: Parsippany, NJ-Hybrid - Onsite T/W/Th
Duration: 12 Months Contract
Payrate: $50/hr - $70/hr on W2
Responsibilities:
• Process Engineer/Validation Engineer a 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.
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
To know more about current opportunities at LeadStack, please visit us at https://leadstackinc.com/careers/
Should you have any questions, feel free to call me on (415) 322-5419or send an email on akarsh.yathiraj@leadstackinc.com
Job Title: Process Monitoring and Data Analytics
Location: Parsippany, NJ-Hybrid - Onsite T/W/Th
Duration: 12 Months Contract
Payrate: $50/hr - $70/hr on W2
Responsibilities:
• Process Engineer/Validation Engineer a 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.
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
To know more about current opportunities at LeadStack, please visit us at https://leadstackinc.com/careers/
Should you have any questions, feel free to call me on (415) 322-5419or send an email on akarsh.yathiraj@leadstackinc.com
| Thanks and Regards Akarsh Yathiraj |
| Senior Recruiter |
| C. | (415) 322-5419 |
| D. | (415) 322-5419 |
| A. | 611 Gateway Blvd, Ste 120 South San Francisco, CA 94080 |
| W. | www.leadstackinc.com |
Source : Leadstack Inc