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Process Engineer, Biotech

Insight Global
Carlsbad, CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

An employer is looking for a Process Engineer to join their team in Carlsbad, CA. The employer is an enterprise level company in the biotech industry and the Process Engineer will be joining a manufacturing group that produces Next Generation Sequencing. The Process Engineer is a critical component for maintaining the Quality Management System and drive improvements through projects. This individual will have the ability drive resolutions to day-to-day quality issues and lead projects for the NGS Department.
The primary responsibilities are as follow:
- Drive safety improvements to promote a safe working environment
- Work within our Quality Management System to effectively perform investigations and identify resolutions related to process failures and deviations
- Participate in internal and external audits and respond to audit observations
- Identify and implement appropriate corrective and preventative actions
- Manage updates of manufacturing records such as WINs, SOPs, and batch records
- Create new processes and or improve processes within manufacturing and QC
- Troubleshoot existing products and processes to recommend and develop/design engineering solutions to address capacity, cost, and quality issues
- Prepare reports and present data to peers, supervisors, and other internal customers
- Create and review project proposals and plans with stakeholders
- Determine project specifications by reviewing performance standards, process requirements, and customer requirements
- Manages project cost, documentation and deadlines to ensure on-time completion
- Drive Practical Process Improvements (PPI) with a high level of team member involvement and engagement, and utilize lean methodologies to realize process efficiencies
- Effectively communicate barriers or issues and obtain needed support for a resolution

 

Requirements:

Bachelor or Associate degree in a Science or Engineer field
2+ years of experience in a manufacturing environment either as a scientist or engineer
1+ years of experience in ISO or cGMP regulated manufacturing environment
Understands Quality investigation methodologies:
- RCCM (root cause counter measure)
- RCA (root cause analysis)
- Fishbone
- 4M+E (Man/Method/Machine/Material/Environment)
- CAPA / CA (Corrective And Preventative Action / Corrective Action)
Understands processes such as Formulation, Filling and Packaging
Experience with Practical Process Improvement (PPI) Systems and tools (or similar Continuous Improvement and Lean Systems)

Insight Global

Address

Carlsbad, CA
USA

Industry

Manufacturing

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