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Engineer Process Support III

Katalyst Healthcares and Lifesciences

North Chicago, Illinois • 16d ago

Full-time

System Engineer III

Kairos Power

Remote or Albuquerque, New Mexico • Today

Full-time

USD 122,270.00 - 143,847.00 per year

Job Details

Skills

Statistical Process Control
Performance Monitoring
Problem Solving
Conflict Resolution
ROOT
Cross-functional Team
Continuous Improvement
Cost Reduction
Project Coordination
Reporting
Management
Documentation
Technical Support
Auditing
Accountability
Regulatory Compliance
Chemistry
Mechanical Engineering
Process Manufacturing
Project Engineering
Pharmaceutics
Communication
English
Manufacturing
Supply Chain Management
Operational Excellence
EHS

Statistical Process Control
Performance Monitoring
Problem Solving
Conflict Resolution
ROOT
Cross-functional Team
Continuous Improvement
Cost Reduction
Project Coordination
Reporting
Management
Documentation
Technical Support
Auditing
Accountability
Regulatory Compliance
Chemistry
Mechanical Engineering
Process Manufacturing
Project Engineering
Pharmaceutics
Communication
English
Manufacturing
Supply Chain Management
Operational Excellence
EHS

Summary

Roles and Responsibilities:

Lead projects in manufacturing process areas to achieve process efficiencies such as increased process yield, quality improvements, cycle time/throughput, and cost reduction initiatives.
Gather and analyze process data using statistical process control methodology. Develop action plans to increase process robustness, prevent product loss, and control quality impact. Participate in process performance monitoring such as Track & Trend.
Provide technical support in the resolution of shop floor situations and execute assigned tasks as required by the operational area.
Lead investigations by following a structured problem-solving approach and employing sound, scientific principles when identifying root cause and developing recommendations related to product and process. Generate technical justification to support and/or document process deviations/investigations and determine impact on product quality, yield, and product registration.
Participate as part of a cross-functional team responsible for implementation of site projects/initiatives, including continuous improvement, cost reduction, capacity increase, etc., that lead to process remediation.
Manage smaller team, short-duration projects within larger projects. Responsibilities may include project coordination, monitoring, reporting, meeting management, and team communication.
Lead the implementation of process validation for operational changes, new raw materials, and introduction of new process/technology. Generate technical justification determining impact of change and protocols/reports/manufacturing documents that support its execution. Assist the execution of experimental, demonstration, and validation lots.
Maintain up-to-date product process documentation and assure they are in compliance with applicable procedures and regulations. Write justification memos and scientific reports of quality controls and manufacturing documents.
Provide scientific and technical support during regulatory audits and agency inspections.
Demonstrate accountability and responsibility for EHS performance and compliance through active participation and support of client's EHS program.

Education and experience:

BS, MS, or PhD in Chemistry or Engineering (Chemical, Mechanical, Bio-chemical, or other relevant scientific field).
7+ years of technical experience in Process/Manufacturing/Project Engineering or similar role.
Technical knowledge in fundamentals of pharmaceutical process (sterile product manufacturing), and site transfer.
Effective verbal and written communication skills in English.

Key Stakeholders:

Manufacturing
Quality
Supply Chain
Operational Excellence
Engineering
EHS

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.

Dice Id: 91116760
Position Id: dd4433a632f28cbadd836e9f8c16c5d5
Posted 30+ days ago

Fitment

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Job Details

Skills

Statistical Process Control
Performance Monitoring
Problem Solving
Conflict Resolution
ROOT
Cross-functional Team
Continuous Improvement
Cost Reduction
Project Coordination
Reporting
Management
Documentation
Technical Support
Auditing
Accountability
Regulatory Compliance
Chemistry
Mechanical Engineering
Process Manufacturing
Project Engineering
Pharmaceutics
Communication
English
Manufacturing
Supply Chain Management
Operational Excellence
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Statistical Process Control
Performance Monitoring
Problem Solving
Conflict Resolution
ROOT
Cross-functional Team
Continuous Improvement
Cost Reduction
Project Coordination
Reporting
Management
Documentation
Technical Support
Auditing
Accountability
Regulatory Compliance
Chemistry
Mechanical Engineering
Process Manufacturing
Project Engineering
Pharmaceutics
Communication
English
Manufacturing
Supply Chain Management
Operational Excellence
EHS

Summary

Roles and Responsibilities:

Lead projects in manufacturing process areas to achieve process efficiencies such as increased process yield, quality improvements, cycle time/throughput, and cost reduction initiatives.
Gather and analyze process data using statistical process control methodology. Develop action plans to increase process robustness, prevent product loss, and control quality impact. Participate in process performance monitoring such as Track & Trend.
Provide technical support in the resolution of shop floor situations and execute assigned tasks as required by the operational area.
Lead investigations by following a structured problem-solving approach and employing sound, scientific principles when identifying root cause and developing recommendations related to product and process. Generate technical justification to support and/or document process deviations/investigations and determine impact on product quality, yield, and product registration.
Participate as part of a cross-functional team responsible for implementation of site projects/initiatives, including continuous improvement, cost reduction, capacity increase, etc., that lead to process remediation.
Manage smaller team, short-duration projects within larger projects. Responsibilities may include project coordination, monitoring, reporting, meeting management, and team communication.
Lead the implementation of process validation for operational changes, new raw materials, and introduction of new process/technology. Generate technical justification determining impact of change and protocols/reports/manufacturing documents that support its execution. Assist the execution of experimental, demonstration, and validation lots.
Maintain up-to-date product process documentation and assure they are in compliance with applicable procedures and regulations. Write justification memos and scientific reports of quality controls and manufacturing documents.
Provide scientific and technical support during regulatory audits and agency inspections.
Demonstrate accountability and responsibility for EHS performance and compliance through active participation and support of client's EHS program.

Education and experience:

BS, MS, or PhD in Chemistry or Engineering (Chemical, Mechanical, Bio-chemical, or other relevant scientific field).
7+ years of technical experience in Process/Manufacturing/Project Engineering or similar role.
Technical knowledge in fundamentals of pharmaceutical process (sterile product manufacturing), and site transfer.
Effective verbal and written communication skills in English.

Key Stakeholders:

Manufacturing
Quality
Supply Chain
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Engineering
EHS

Dice Id: 91116760
Position Id: dd4433a632f28cbadd836e9f8c16c5d5
Posted 30+ days ago

Fitment

Dice Job Match Score™

To see how well you match this job, please log in or create an account.

Once logged in, be sure to complete your profile to get the most accurate match score.

Create job alert

Never miss an opportunity! Create an alert based on the job you applied for.

Similar Jobs

Engineer Process Support III

Illinois

•

16d ago

Full-time

Associate Director, Process Technology

Kankakee, Illinois

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Compensation information provided in the description

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Delaware

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