• Snapboard
  • Activity
  • Reports
  • Campaign
Welcome ,

Chat with the recruiter

...Minimize

Hey I'm Online! Leave me a message.
Let me know if you have any questions.

BioProcess Engineer

In California / United States

Save this job

BioProcess Engineer   

Click on the below icons to share this job to Linkedin, Twitter!
JOB TITLE:
BioProcess Engineer
JOB TYPE:

JOB SKILLS:
JOB LOCATION:
San Jose California / United States

JOB DESCRIPTION :
Pay rate - $47.24/hr
Work hours: 8am - 5pm


• 3 Must haves:
1. Experience in developing manufacturing processes and QC test methods.
2. Experience in document creation, BOMs, Routings, etc
3. Experience in writing protocols & reports with justification for design and acceptance criteria for regulated products.
4. some level of experience in process validation is preferred, QC test method validation, Gage studies, writing, executing DOEs, Troubleshooting manufacturing failures

JOB SUMMARY

Represents reagent operations in new product teams responsible for the development, scale up, validation, creating new product documentation and transfer of production processes to Operations. May determine methods and procedures on new assignments.

DUTIES AND RESPONSIBILITIES


1. Develop, scale up and setup the manufacturing processes to optimize process flow, reduce variability within the process, and improve operating capabilities.
2. Work with R&D team to develop and validate the QC test methods.
3. Prepares and submits SOP’s, WI’s, BOM’s, routings and standard costing for new product into SAP
4. Works with the team to design, write and execute Gage R&R, scale up, stability, and validation studies and associated reports.
5. Promotes a safe work environment.


MINIMUM QUALIFICATIONS

Education and Experience:

• Requires a minimum of a Bachelor’s degree in biological sciences with 5 years of relevant experience or Master’s degree with minimum of 3 years of relevant experience.
• A minimum of 3 year experience in a FDA or ISO regulated medical device production environment.
• Knowledge in antibody techniques, molecular biology techniques, instrumentation, and assays performed
• Experience in developing the manufacturing process and QC test method is must.
• Experience in document creation, BOMs, Routings, etc
• Experience in writing protocols & reports with justification for design and acceptance criteria for regulated products.
• Experience in SAP is highly preferred
• Experience in statistical analysis, 6 Sigma Greenbelt or Lean Manufacturing certification preferred.


Position Details

Jun 12, 2021
S16204861301058943
California / United States
San Jose
A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

BioProcess Engineer    Apply

Click on the below icons to share this job to Linkedin, Twitter!

Pay rate - $47.24/hr
Work hours: 8am - 5pm


• 3 Must haves:
1. Experience in developing manufacturing processes and QC test methods.
2. Experience in document creation, BOMs, Routings, etc
3. Experience in writing protocols & reports with justification for design and acceptance criteria for regulated products.
4. some level of experience in process validation is preferred, QC test method validation, Gage studies, writing, executing DOEs, Troubleshooting manufacturing failures

JOB SUMMARY

Represents reagent operations in new product teams responsible for the development, scale up, validation, creating new product documentation and transfer of production processes to Operations. May determine methods and procedures on new assignments.

DUTIES AND RESPONSIBILITIES


1. Develop, scale up and setup the manufacturing processes to optimize process flow, reduce variability within the process, and improve operating capabilities.
2. Work with R&D team to develop and validate the QC test methods.
3. Prepares and submits SOP’s, WI’s, BOM’s, routings and standard costing for new product into SAP
4. Works with the team to design, write and execute Gage R&R, scale up, stability, and validation studies and associated reports.
5. Promotes a safe work environment.


MINIMUM QUALIFICATIONS

Education and Experience:

• Requires a minimum of a Bachelor’s degree in biological sciences with 5 years of relevant experience or Master’s degree with minimum of 3 years of relevant experience.
• A minimum of 3 year experience in a FDA or ISO regulated medical device production environment.
• Knowledge in antibody techniques, molecular biology techniques, instrumentation, and assays performed
• Experience in developing the manufacturing process and QC test method is must.
• Experience in document creation, BOMs, Routings, etc
• Experience in writing protocols & reports with justification for design and acceptance criteria for regulated products.
• Experience in SAP is highly preferred
• Experience in statistical analysis, 6 Sigma Greenbelt or Lean Manufacturing certification preferred.