Process Engineer Job New Brunswick area,New Jersey USA,Engineering

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/Mini Tab/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(@) or .

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