Manufacturing Engineer - GMP Biotech Process Excellence

SaniSure; Camarillo (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

SaniSure in Camarillo, California, seeks a Manufacturing Engineer to lead process engineering and improvement efforts in a GMP environment. This role focuses on optimizing production efficiency, regulatory compliance, and supporting new product introductions.

The ideal candidate will have a Bachelor's degree in a STEM field, plus 5+ years of manufacturing engineering experience, particularly in medical devices or pharmaceuticals. Strong skills in Lean Six Sigma methodologies are essential.

Qualifications

• 5+ years of hands-on manufacturing engineering experience in a regulated environment.
• Solid proficiency in Lean Six Sigma tools and methodologies.
• Experience with IQ/OQ/PQ protocols and process qualifications.

Responsibilities

• Lead process engineering and continuous improvement efforts.
• Develop process flow diagrams, SOPs, and work instructions.
• Support NPI manufacturing readiness activities and validation runs.

Skills

Lean Six Sigma tools

Statistical Process Control (SPC)

Root Cause Corrective Action (RCCA)

Process validation

Engineering drawings interpretation

Education

Bachelor's degree in Mechanical Engineering or related STEM field

Tools

CAD software

Gage R&R

Job description

SaniSure in Camarillo, California, seeks a Manufacturing Engineer to lead process engineering and improvement efforts in a GMP environment. This role focuses on optimizing production efficiency, regulatory compliance, and supporting new product introductions.

The ideal candidate will have a Bachelor's degree in a STEM field, plus 5+ years of manufacturing engineering experience, particularly in medical devices or pharmaceuticals. Strong skills in Lean Six Sigma methodologies are essential.