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Open nowPosted 3374 days ago

Process Engineer

Artech Information System LLC1,272 open roles

Where
New Brunswick, NJ, United States
Work mode
On site
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Your applicationOpen nowProcess EngineerArtech Information System LLC · New Brunswick, NJ, United States

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Share of postings closed within
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  2. 4.3%3 days
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  4. 18.1%14 days
  5. 35.6%30 days
  6. 44.6%60 days
This job: posted 3374 days ago

The posting

Company Description

Big Pharmaceutical Organisation

Job Description

Associate Process Engineer/Scientist- Drug Product, Biologics Manufacturing Science and Technology

Key responsibilities include

• Execution of post-market process change activities/experiments through partnership with R&D development assets • Responsible for characterizing, optimizing and troubleshooting product and manufacturing processes of parenteral dosage forms. • Work with R&D and manufacturing sites to design and execute experiments to support product robustness, new technology implementation, and/or manufacturing investigations • Serve as technical resource to other functions, providing expertise on the product and its process. • Effectively represent biologics drug product manufacturing science and technology in various internal and external teams and committees on development, technology transfer, manufacturing, specifications, process validations and launch. • Provide assistance to sites globally to resolve significant quality events and manage complex change controls.

Qualifications

• Bachelor’s degree in relevant science or engineering discipline (chemistry, pharmaceutical sciences, pharmacy, biology, chemical engineering). • Master or advanced degree preferred. • Minimum of 3-5 years of experience in the Pharmaceutical or Biotechnology industry in product and process development and commercialization in a global environment. Key Skills and Experience • Hands-on experience in the laboratory and in-depth understanding in sterile and liquid products, particularly biologics, formulation development, analytical methods, commercial manufacturing, and their unit operations. • In-depth understanding of Quality by Design (QbD), Design of Experiments (DOE), multivariate analysis, PAT, critical process and material attributes and CQA's. • Working competency of Statistical Process Control and related tools (JMP/MiniTab/SAS). • Able to design and execute scientifically sound, hypothesis driven experiments • Skilled in writing and reviewing complex study plans and scientific reports. • Possess high level of familiarity with sterile product processing equipment and manufacturing facilities. • Overall knowledge of parenteral technology: aseptic processing, sterilization, isolator processing, lyophilization, pre-filled syringe operations, etc. • Strong understanding of project management systems and tools • Six Sigma Green/Black Belt certification desirable

Additional Information

Interested candidates may contact at "Praveen.arora(@)artechinfo.com or 973-507-7593

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