Monster

Process Monitoring and Data Analytics

Careers Integrated Resources Inc

Parsippany-Troy Hills, NJ

JOB DETAILS
SKILLS
BASIC Programming Language, Biological Processes, Communication Skills, Data Analysis, Data Collection, Data Management, Data Processing, FDA (Food and Drug Administration), GMP (Good Manufacturing Practices), ICH Regulations, Identify Issues, Interpersonal Skills, Maintain Compliance, Manufacturing Requirements, Minitab, Multitasking, Policy Development, Presentation/Verbal Skills, Problem Solving Skills, Process Engineering, Process Validation, Project/Program Management, Python Programming/Scripting Language, R Programming Language, Regulations, Regulatory Requirements, Standard Operating Procedures (SOP), Statistics, Technical Writing, Writing Skills
LOCATION
Parsippany-Troy Hills, NJ
POSTED
29 days ago

Job Title: Process Monitoring and Data Analytics
Job Location: Parsippany, NJ
Job Duration: 12 Months +(Possible Extension)

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:
• 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.

About the Company

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Careers Integrated Resources Inc