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BioProcess/NPI Engineer

In California / United States

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BioProcess/NPI Engineer   

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JOB TITLE:

BioProcess/NPI Engineer

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

San Jose California / United States

JOB DESCRIPTION:

Max pay rate of $39.37/hour;
Work hours: 9 to 5

mostly on-site , must be local

3 Must haves on the resume:
Hands on PCR, NGS, molecular biology
Understanding of technical issues, problem solving
Protocol writing


New Product transfer scientist I: Reagent Operations

JOB SUMMARY

With supervision, participates in new product teams responsible for the development, scale up, validation and transfer of production processes to Operations. Works on problems where analysis of situations or data requires an evaluation of various factors. Assists in improving process efficiency and product quality. May determine methods and procedures on new assignments, and may provide guidance to other lower level associates.

DUTIES AND RESPONSIBILITIES


1. Work in new product transfer of single cell Multiomics products.
2. May participate as a member of the operation team and support core team member
3. Assist in the successful transfer of products and processes into manufacturing following the Global Product Development System
a. Develop, scale up and setup the manufacturing processes.
b. Prepares and submits SOP, WI, BOM, routings and standard costing for new products into SAP
4. Supports validation activities.
5. Supports senior BPEs to analyze and solve problems in Production and Quality Control. Provides support in experimental strategy, problem characterization, data acquisition and analysis.
6. Support root cause analysis for product complaints through experiments involving flow cytometry/applications and production process evaluations including physical property or analytical data analysis.
7. Supports in the designing, writing and executing of protocols, reports, data analysis and other quality documents.
8. May provide recommendations for process improvements.
9. Trains manufacturing associates in new processes and procedures
10. Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements and raises concerns/issues to the management.
11. Promotes a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices





MINIMUM QUALIFICATIONS

Education and Experience:

• Requires a minimum of a Bachelor’s degree in biological sciences and a minimum of 3 year of hands on laboratory experience in a reagent process development or reagent manufacturing environent or Master’s degree in related field.
• Working knowledge of molecular biology techniques like PCR, NGS required
• A minimum of 1 year experience in a FDA or ISO/GMP regulated production environment

Assets

• Knowledge of general laboratory safety, GMP's and associated regulatory requirements
• Experience in writing protocols & reports with justification for design and acceptance criteria for regulated products.
• Experience with SAP

Position Details

POSTED:

Aug 08, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204860883635511

LOCATION:

California / United States

CITY:

San Jose

Job Origin:

Jobsrus_organic_feed

A job sourcing event
In Dallas Fort Worth
Aug 19, 2017 9am-6pm
All job seekers welcome!

BioProcess/NPI Engineer    Apply

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

Max pay rate of $39.37/hour;
Work hours: 9 to 5

mostly on-site , must be local

3 Must haves on the resume:
Hands on PCR, NGS, molecular biology
Understanding of technical issues, problem solving
Protocol writing


New Product transfer scientist I: Reagent Operations

JOB SUMMARY

With supervision, participates in new product teams responsible for the development, scale up, validation and transfer of production processes to Operations. Works on problems where analysis of situations or data requires an evaluation of various factors. Assists in improving process efficiency and product quality. May determine methods and procedures on new assignments, and may provide guidance to other lower level associates.

DUTIES AND RESPONSIBILITIES


1. Work in new product transfer of single cell Multiomics products.
2. May participate as a member of the operation team and support core team member
3. Assist in the successful transfer of products and processes into manufacturing following the Global Product Development System
a. Develop, scale up and setup the manufacturing processes.
b. Prepares and submits SOP, WI, BOM, routings and standard costing for new products into SAP
4. Supports validation activities.
5. Supports senior BPEs to analyze and solve problems in Production and Quality Control. Provides support in experimental strategy, problem characterization, data acquisition and analysis.
6. Support root cause analysis for product complaints through experiments involving flow cytometry/applications and production process evaluations including physical property or analytical data analysis.
7. Supports in the designing, writing and executing of protocols, reports, data analysis and other quality documents.
8. May provide recommendations for process improvements.
9. Trains manufacturing associates in new processes and procedures
10. Keeps abreast of the basic requirements for compliance in own area of work and complies with those requirements and raises concerns/issues to the management.
11. Promotes a safe work environment. May provide recommendations on maintaining the safety of the work environment. Participates in Environmental Health and Safety programs. Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work practices





MINIMUM QUALIFICATIONS

Education and Experience:

• Requires a minimum of a Bachelor’s degree in biological sciences and a minimum of 3 year of hands on laboratory experience in a reagent process development or reagent manufacturing environent or Master’s degree in related field.
• Working knowledge of molecular biology techniques like PCR, NGS required
• A minimum of 1 year experience in a FDA or ISO/GMP regulated production environment

Assets

• Knowledge of general laboratory safety, GMP's and associated regulatory requirements
• Experience in writing protocols & reports with justification for design and acceptance criteria for regulated products.
• Experience with SAP


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