Process Engineer (CPV) - Pharma/Biotech/Medical Device) - Hybrid role!!

No H1B and/or C2C please!!

One of our leading Pharmaceutical client is looking for a Process Monitoring and Data Analytics, who must have experience in statistics, process monitoring and advanced statistical data analysis.

Job Title: Process Monitoring and Data Analytics

W2 Contract & Hybrid role (3 day onsite)

Work Location: Parsippany, NJ

Required Education & Experience:-

• Strong background in statistics, process monitoring and advanced statistical data analysis.
• Experience in commercial biologics Continued Process Verification (CPV) program strategies and contribute to CPV program of one or multiple biologics products.
• 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
• Understanding of guidelines required by FDA, EMA, and other regulatory bodies

Responsibilities:-

• Supporting in batch processing data collection and verification activities.
• Author, review and approve CPV protocols, reports and present CPV data as needed to Subject Matter Experts (SMEs).
• 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.

If you are a right fit as per the skills requirements and this job excites you then please apply quick!!