Pharma Manufacturing Engineer - Process Optimization & CAPA

Kindeva

Los Angeles (CA)

On-site

USD 85,000 - 110,000

Full time

5 days ago
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Job summary

Kindeva is seeking a qualified engineer to support 24/7 manufacturing operations, troubleshoot processes, and drive improvements across multiple production lines. The role emphasizes safety, quality, reliability, and productivity while coordinating with cross-functional teams.

Your experience in pharma/biotech manufacturing, root cause analysis, and change control will help ensure continuous improvement and regulatory compliance in a high-paced environment.

Qualifications

  • Bachelor's degree in engineering or equivalent plus manufacturing experience.
  • 3+ years in pharma/biotech/medical device manufacturing preferred.
  • Working knowledge of root cause investigation methodologies and corrective actions.
  • Familiar with cGMP requirements, quality systems, change control, deviations, and CAPA processes.
  • Experience troubleshooting manufacturing processes and production issues.

Responsibilities

  • Provide daily technical support for assigned production lines.
  • Troubleshoot equipment, process, and quality issues.
  • Lead root cause investigations and corrective actions.
  • Maintain visibility of online performance, downtime, and recurring issues.
  • Serve as engineering owner for assigned manufacturing processes.
  • Manage action items and closure of corrective actions.
  • Support OEE, uptime, yield, scrap reduction, and throughput improvements.
  • Develop and implement process improvements and participate in validation activities.
  • Maintain documentation and engineering records.
  • Support CAPA, deviations, and audits; ensure 24/7 operation readiness.

Skills

Root cause investigations
cGMP knowledge
Project management
Technical troubleshooting
Written & verbal communication
Cross-functional collaboration

Education

Bachelor's degree in mechanical, electrical, systems engineering, manufacturing or related

Tools

Microsoft Office
Engineering documentation systems
MES

Job description

Kindeva is seeking a qualified engineer to support 24/7 manufacturing operations, troubleshoot processes, and drive improvements across multiple production lines. The role emphasizes safety, quality, reliability, and productivity while coordinating with cross-functional teams.

Your experience in pharma/biotech manufacturing, root cause analysis, and change control will help ensure continuous improvement and regulatory compliance in a high-paced environment.

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