Process Development Engineer

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap – Right Talent – Right Time – Right Place – Right Price and acting as a Career Coach to our consultants.

Company: One of Our Clients

JOB DESCRIPTION:

Position: Process Monitoring and Data Analytics

Location: Parsippany, NJ 07054 (3 days a week onsite)

Duration: 12+ Months (Extendable)

Pay Rate: $70 – 73/hr on W2

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.

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.

Awards and Accolades:

• America's Most Honored Businesses (Top 10%)
• Awarded by USPAAC for Fastest Growing Business in the US
• 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020)
• Fastest 50 by NJ Biz (2020, 2019, 2020)
• INC 5000 Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list)
• Top 100 by Dallas Business Journal (2020 and 2019)
• Proven Supplier of the Year by Workforce Logiq (2020 and 2019)
• 2019 Spirit of Alliance Award by Agile1
• 2018 Best of the Best Platinum Award by Agile1
• 2018 TechServe Alliance Excellence Awards Winner
• 2017 Best of the Best Gold Award by Agile1(Act1 Group)

Regards,

Kajal Singh

Associate IT Recruiter (Pharma and Life Sciences)

Net2Source Inc.

Global HQ Address –270 Davidson Ave, Suite 704, Somerset, NJ 08873, USA

Office: (201) 340-8700 x 980 | Cell: (201) 777-4217 | Fax: (201) 221-8131| Email: singh.kajal@net2source.com