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Process Engineer

Job Description

JOB TITLE: PROCESS ENGINEER

DURATION:12 MONTHS CONTRACT

LOCATION:WARREN,NJ

Looking for a Process Engineer to join the External team within the Cell Therapy GMSAT (Global Manufacturing Science and Technology) department. The position will be responsible for the routine MSAT support to our ex-US CMO partners. This engineer will have responsibilities like an internal MSAT organization for Client's'S cell therapy drug product manufacturing site with the focus on supplementing the technical capabilities of the CMO and driving continuous improvement.

Responsibilities:

  • Provide technical process support for routine clinical and/or commercial cell therapy manufacturing at the CMO.
  • Support production related investigations, ensuring compliance with internal standards and regulatory requirements
  • Identify and propose continuous process improvement projects to management.
  • Support process and procedural changes to improve manufacturing performance, robustness, productivity, safety, and efficiency.
  • Perform monitoring of manufacturing processes to understand process capability.
  • Implement and support the execution of process control strategies including execution of process risk assessments, and continued process verification.
  • Leverage and maintain strong relationships with external partners
  • Support product implementations in coordination with Development, Manufacturing, and Quality groups, including visits to contract manufacturing sites
  • Maintain permanent inspection readiness and actively support regulatory inspections
  • Ensure manufacturing processes are in a state of control, harmonized across the cell therapy manufacturing network
  • Share operational and process leaning with the rest of the manufacturing network.

Education and Experience:

  • B.S. with 4-6 years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline
  • Two years of extensive experience in a regulated GMP manufacturing environment (clinical and/or commercial)
  • Experience working within Quality Management systems including providing deviation, investigation, and CAPA support
  • Experience with cellular therapies is strongly preferred
  • Established track record of success with sound technical qualifications and knowledge in process development, characterization, and troubleshooting
  • Familiarity with literature on process development and cell therapy
  • Excellent communication, writing, organizational, teamwork, and presentation skills

Strong interpersonal and leadership skills to work with teams in different functions and organizations

Additional Skills: * B.S. with 4-6 years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline* Two years of extensive experience in a regulated GMP manufacturing environment (clinical and/or commercial)* Experience working within Quality Management systems including providing deviation, investigation, and CAPA support* Experience with cellular therapies is strongly preferred* Established track record of success with sound technical qualifications and knowledge in process development, characterization, and troubleshooting* Familiarity with literature on process development and cell therapy* Excellent communication, writing, organizational, teamwork, and presentation skillsStrong interpersonal and leadership skills to work with teams in different functions and organizations

Job Requirements

 

Job Snapshot

Location US-NJ-Warren
Employment Type Contractor
Pay Type Year
Pay Rate N/A
Store Type Other
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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-Warren
AIC
(678)207-5259
Snapshot
Analysts
Company:
US-NJ-Warren
Location:
Contractor
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Other
Store Type:

Job Description

JOB TITLE: PROCESS ENGINEER

DURATION:12 MONTHS CONTRACT

LOCATION:WARREN,NJ

Looking for a Process Engineer to join the External team within the Cell Therapy GMSAT (Global Manufacturing Science and Technology) department. The position will be responsible for the routine MSAT support to our ex-US CMO partners. This engineer will have responsibilities like an internal MSAT organization for Client's'S cell therapy drug product manufacturing site with the focus on supplementing the technical capabilities of the CMO and driving continuous improvement.

Responsibilities:

  • Provide technical process support for routine clinical and/or commercial cell therapy manufacturing at the CMO.
  • Support production related investigations, ensuring compliance with internal standards and regulatory requirements
  • Identify and propose continuous process improvement projects to management.
  • Support process and procedural changes to improve manufacturing performance, robustness, productivity, safety, and efficiency.
  • Perform monitoring of manufacturing processes to understand process capability.
  • Implement and support the execution of process control strategies including execution of process risk assessments, and continued process verification.
  • Leverage and maintain strong relationships with external partners
  • Support product implementations in coordination with Development, Manufacturing, and Quality groups, including visits to contract manufacturing sites
  • Maintain permanent inspection readiness and actively support regulatory inspections
  • Ensure manufacturing processes are in a state of control, harmonized across the cell therapy manufacturing network
  • Share operational and process leaning with the rest of the manufacturing network.

Education and Experience:

  • B.S. with 4-6 years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline
  • Two years of extensive experience in a regulated GMP manufacturing environment (clinical and/or commercial)
  • Experience working within Quality Management systems including providing deviation, investigation, and CAPA support
  • Experience with cellular therapies is strongly preferred
  • Established track record of success with sound technical qualifications and knowledge in process development, characterization, and troubleshooting
  • Familiarity with literature on process development and cell therapy
  • Excellent communication, writing, organizational, teamwork, and presentation skills

Strong interpersonal and leadership skills to work with teams in different functions and organizations

Additional Skills: * B.S. with 4-6 years of relevant experience in Biochemical, Chemical, or Biomedical Engineering or Cell Biology/Immunology discipline* Two years of extensive experience in a regulated GMP manufacturing environment (clinical and/or commercial)* Experience working within Quality Management systems including providing deviation, investigation, and CAPA support* Experience with cellular therapies is strongly preferred* Established track record of success with sound technical qualifications and knowledge in process development, characterization, and troubleshooting* Familiarity with literature on process development and cell therapy* Excellent communication, writing, organizational, teamwork, and presentation skillsStrong interpersonal and leadership skills to work with teams in different functions and organizations

Job Requirements

 
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