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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



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


Carlsbad, CA



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