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Process Engineer

Job Description

ACS Solutions has an immediate need for a Process Engineer, with experience in the Pharmaceutical Industry. This is a 12 month contract opportunity and is located in Warren NJ. Our client is a leading Pharmaceutical company.

Please review the job description below:

Job Summary:

We are 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 cell therapy drug product manufacturing site with the focus on supplementing the technical capabilities of the CMO and driving continuous improvement. This person may be responsible for and support processes including PPQ, commercial launch, and commercial manufacturing support. The Process Engineer will support product lifecycle management, including commercialization and evolution of cell therapy products as well as day to day operations technical support at CMOs to ensure reliable quality supply. The role will be highly cross-functional and will interact with other CTDO/GPDO groups and in-country affiliates in establishing manufacturing and technology capability, CMO selection, facility fit and design, equipment selection, and facility start up work force training.

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

If it creates an interest for you, please email me the latest copy of your resume.

Thanks,

Charu Yadav

609-402-4331


ABOUT ACS SOLUTIONS.
- ACS Solutions 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-Warren
Employment Type Contractor
Pay Type Year
Pay Rate N/A
Store Type Energy, Oil & Gas, Engineering & Aerospace, Clinical & Scientific
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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)203-3342
Snapshot
Analysts
Company:
US-NJ-Warren
Location:
Contractor
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Energy, Oil & Gas, Engineering & Aerospace, Clinical & Scientific
Store Type:

Job Description

ACS Solutions has an immediate need for a Process Engineer, with experience in the Pharmaceutical Industry. This is a 12 month contract opportunity and is located in Warren NJ. Our client is a leading Pharmaceutical company.

Please review the job description below:

Job Summary:

We are 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 cell therapy drug product manufacturing site with the focus on supplementing the technical capabilities of the CMO and driving continuous improvement. This person may be responsible for and support processes including PPQ, commercial launch, and commercial manufacturing support. The Process Engineer will support product lifecycle management, including commercialization and evolution of cell therapy products as well as day to day operations technical support at CMOs to ensure reliable quality supply. The role will be highly cross-functional and will interact with other CTDO/GPDO groups and in-country affiliates in establishing manufacturing and technology capability, CMO selection, facility fit and design, equipment selection, and facility start up work force training.

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

If it creates an interest for you, please email me the latest copy of your resume.

Thanks,

Charu Yadav

609-402-4331


ABOUT ACS SOLUTIONS.
- ACS Solutions 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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