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USA-Process Engineer III (Engineering)

Job Description

Process Engineer III #21-03170
Ridgefield, NJ
**Local Candidates
 
Job Description:
  • Develop process design basis, including sizing and selection of equipment, mass balance, URS and instrumentation for control of robust processes.
  • Provide input to industrialization strategies and rationale for critical process parameters. Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations.
  • Responsible for process design and continuous improvements, support execution and documentation of development and/or validation studies and lead or supervise groups and/task force in the planning of engineering, investigational, definition and process validation runs.
  • Document and interpret study results with recommendations.
  • Provide technical leadership as a subject matter expert in multiple areas of responsibility. Document and interpret study results with recommendations.
  • Execute life-cycle design and industrialization of upstream processes, products and associated test methods for Phase 3 and licensed products (new vaccines and biopharmaceuticals AND life-cycle improvements) to assure commercialization of robust, compliant, and efficient processes and test methods for vaccines and biopharmaceuticals.
  • Input to design space/DOE studies through establishment of scale-up/scale-down parameters utilizing engineering fundamentals (mixing, mas /heat transfer, modeling, dimensionless parameters, etc.) and process control strategies.
  • Partner with engineering to ensure industrial implementation of process design, including review of engineering design documents, provide review and input to C&Q strategy and participating in testing of equipment.
Job Requirements:
  • Bachelor's Degree/Undergraduate Degree or Advanced Degree in chemical or biochemical engineering.
  • Minimum of 5 years’ experience and a bachelor’s degree (bare minimum)
  • Advanced degree in sciences with 10+ year’s large-scale process equipment design, scale-up implementation & validation experience **preferred.
  • Help create specifications for materials and excipients.
  • Provide technical assistance to manufacturing and quality operations for process troubleshooting, and health authority inspections to achieving site metrics (+QDCI).
  • Expertise in fill/finish, aseptic manufacturing or packaging operations as well as project/engineering lifecycle.
  • Knowledge of computer software common to mission (AutoCAD, process simulation/scheduling, CFD) is preferred.
  • Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation and control.
  • Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
  • Experience in equipment start-up, qualification and validation is preferred.
  • Looking for process engineering experience with sterile product, sterile filling and packaging.
  • *This is onsite/remote hybrid but more onsite.

Job Requirements

 

Job Snapshot

Location US-NJ-Ridgefield
Employment Type Contractor
Pay Type Hour
Pay Rate N/A
Store Type Clinical & Scientific
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Company Overview

Ascent

The Ascent Services Group (ASG) is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. ASG’s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Learn More

Contact Information

US-NJ-Ridgefield
Soma Emmadi
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Snapshot
Ascent
Company:
US-NJ-Ridgefield
Location:
Contractor
Employment Type:
Hour
Pay Type:
N/A
Pay Rate:
Clinical & Scientific
Store Type:

Job Description

Process Engineer III #21-03170
Ridgefield, NJ
**Local Candidates
 
Job Description:
  • Develop process design basis, including sizing and selection of equipment, mass balance, URS and instrumentation for control of robust processes.
  • Provide input to industrialization strategies and rationale for critical process parameters. Subject Matter Expert (SME) for development and validation, health authority inspections, and investigations.
  • Responsible for process design and continuous improvements, support execution and documentation of development and/or validation studies and lead or supervise groups and/task force in the planning of engineering, investigational, definition and process validation runs.
  • Document and interpret study results with recommendations.
  • Provide technical leadership as a subject matter expert in multiple areas of responsibility. Document and interpret study results with recommendations.
  • Execute life-cycle design and industrialization of upstream processes, products and associated test methods for Phase 3 and licensed products (new vaccines and biopharmaceuticals AND life-cycle improvements) to assure commercialization of robust, compliant, and efficient processes and test methods for vaccines and biopharmaceuticals.
  • Input to design space/DOE studies through establishment of scale-up/scale-down parameters utilizing engineering fundamentals (mixing, mas /heat transfer, modeling, dimensionless parameters, etc.) and process control strategies.
  • Partner with engineering to ensure industrial implementation of process design, including review of engineering design documents, provide review and input to C&Q strategy and participating in testing of equipment.
Job Requirements:
  • Bachelor's Degree/Undergraduate Degree or Advanced Degree in chemical or biochemical engineering.
  • Minimum of 5 years’ experience and a bachelor’s degree (bare minimum)
  • Advanced degree in sciences with 10+ year’s large-scale process equipment design, scale-up implementation & validation experience **preferred.
  • Help create specifications for materials and excipients.
  • Provide technical assistance to manufacturing and quality operations for process troubleshooting, and health authority inspections to achieving site metrics (+QDCI).
  • Expertise in fill/finish, aseptic manufacturing or packaging operations as well as project/engineering lifecycle.
  • Knowledge of computer software common to mission (AutoCAD, process simulation/scheduling, CFD) is preferred.
  • Proficient with structured methodologies such as Good Engineering Practices, Quality by Design, Design Space, & Process Control Strategies to be employed in the course of industrial process design, validation and control.
  • Ability to work in cross functional teams, provide strong analytical skills for troubleshooting and root cause analysis, and communicate with internal and external team members.
  • Experience in equipment start-up, qualification and validation is preferred.
  • Looking for process engineering experience with sterile product, sterile filling and packaging.
  • *This is onsite/remote hybrid but more onsite.

Job Requirements

 
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