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Assistant Process Engineer

Job Description

ACS group has an immediate need for a 'Assistant Process Engineer' with experience in the Pharmaceutical Industry. This is a 6 - month contract opportunity and is located in New Brunswick, NJ. Our client is a leading Pharmaceutical company.

Please review the job description below:

Top Skills:

  • Process Engineer
  • Drug development
  • Laboratory
  • Sterile products
  • Pharmaceutical

Key Requirements and Technology Experience:

The Process Engineer/Scientist conducts product and process characterization studies; collaborates with research and development in drug product process development of sterile parenteral and biologics drug product and works with manufacturing sites to characterize, troubleshoot or optimize processes for lifecycle products. This position is accountable for the design and execution of process characterization to ensure design and transfer of robust manufacturing processes for new products and key life cycle management products, development of new technology for optimization and continuous improvement in manufacturing operations, and providing specialized expertise as necessary to complement site capabilities for critical investigations or process improvements.

MAJOR DUTIES AND RESPONSIBILITIES

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

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.

Education:

Bachelor's degree in relevant science or engineering discipline (chemistry, pharmaceutical sciences, pharmacy, biology, chemical engineering). Master or advanced degree preferred.

Experience / Knowledge Desired:

  • Minimum of 3-5 years of experience in the Pharmaceutical or Biotechnology industry in product and process development and commercialization in a global environment.
  • Hands-on experience in the laboratory and in-depth understanding in sterile and liquid products, particularly biologics, formulation development, analytical methods, commercial drug product 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.
  • 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

Thanks & Regards


RAHUL GULATI

Team Recruitment

P: (+1) 404-585-5612


ABOUT ACS GROUP.
- ACS Group is a premier provider of IT Consulting, Engineering Consulting, Healthcare, Talent, and Workforce Management Solutions to Fortune 1000 companies globally. Our operating brands have provided targeted services and solutions for more than 50 years. We serve our clients through four operating companies:
* AIC
*Analysts
*ComforceHealth
*HireGenics
Recent Recognitions:
#No. 6 Largest IT staffing Firm in the U.S. (2019 SIA)
#Largest Minority-Owned IT Staffing Firm in the U.S. (2018 SIA)
# No. 8 Largest IT Staffing Firm in the U.S. (2018 SIA)
#Inavero's Best of Staffing® Client Diamond Award (2018).
#National Class lV Supplier of the Year Finalist and a Regional Class IV Supplier of the Year by NMSDC
#Inavero's Best of Staffing®Client Diamond Award Winner(2017)

Website: www.acsicorp.com

Job Requirements

 

Job Snapshot

Location US-NJ-New Brunswick
Employment Type Contractor
Pay Type Year
Pay Rate N/A
Store Type Engineering & Aerospace
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Company Overview

Analysts

Analysts International Corporation (AIC) is an IT services firm fully dedicated to the success and satisfaction of its customers. From IT staffing to project-based solutions, AIC provides a broad range of services designed to help businesses and government agencies drive value, control costs and deliver on the promise of a more efficient and productive enterprise. Learn More

Contact Information

US-NJ-New Brunswick
AIC
(404)585-5612
Snapshot
Analysts
Company:
US-NJ-New Brunswick
Location:
Contractor
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Engineering & Aerospace
Store Type:

Job Description

ACS group has an immediate need for a 'Assistant Process Engineer' with experience in the Pharmaceutical Industry. This is a 6 - month contract opportunity and is located in New Brunswick, NJ. Our client is a leading Pharmaceutical company.

Please review the job description below:

Top Skills:

  • Process Engineer
  • Drug development
  • Laboratory
  • Sterile products
  • Pharmaceutical

Key Requirements and Technology Experience:

The Process Engineer/Scientist conducts product and process characterization studies; collaborates with research and development in drug product process development of sterile parenteral and biologics drug product and works with manufacturing sites to characterize, troubleshoot or optimize processes for lifecycle products. This position is accountable for the design and execution of process characterization to ensure design and transfer of robust manufacturing processes for new products and key life cycle management products, development of new technology for optimization and continuous improvement in manufacturing operations, and providing specialized expertise as necessary to complement site capabilities for critical investigations or process improvements.

MAJOR DUTIES AND RESPONSIBILITIES

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

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.

Education:

Bachelor's degree in relevant science or engineering discipline (chemistry, pharmaceutical sciences, pharmacy, biology, chemical engineering). Master or advanced degree preferred.

Experience / Knowledge Desired:

  • Minimum of 3-5 years of experience in the Pharmaceutical or Biotechnology industry in product and process development and commercialization in a global environment.
  • Hands-on experience in the laboratory and in-depth understanding in sterile and liquid products, particularly biologics, formulation development, analytical methods, commercial drug product 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.
  • 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

Thanks & Regards


RAHUL GULATI

Team Recruitment

P: (+1) 404-585-5612


ABOUT ACS GROUP.
- ACS Group is a premier provider of IT Consulting, Engineering Consulting, Healthcare, Talent, and Workforce Management Solutions to Fortune 1000 companies globally. Our operating brands have provided targeted services and solutions for more than 50 years. We serve our clients through four operating companies:
* AIC
*Analysts
*ComforceHealth
*HireGenics
Recent Recognitions:
#No. 6 Largest IT staffing Firm in the U.S. (2019 SIA)
#Largest Minority-Owned IT Staffing Firm in the U.S. (2018 SIA)
# No. 8 Largest IT Staffing Firm in the U.S. (2018 SIA)
#Inavero's Best of Staffing® Client Diamond Award (2018).
#National Class lV Supplier of the Year Finalist and a Regional Class IV Supplier of the Year by NMSDC
#Inavero's Best of Staffing®Client Diamond Award Winner(2017)

Website: www.acsicorp.com

Job Requirements

 
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