GMP Quality Engineer — 3rd Shift (Pharma)

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

Otsuka ICU Medical LLC is seeking a Manufacturing Quality Engineer I to oversee GMP compliance in manufacturing operations and coach staff on quality and procedural standards. The role includes performing safety inspections, batch record reviews, and CAPA investigations.

The position requires a Bachelor’s degree in Engineering, 0-2 years of experience, and preferably prior pharma exposure. Clean room experience is desirable and travel is typically minimal.

Qualifications

• Bachelor's degree in Engineering or related STEM field.
• 0-2 years of experience required; pharma experience preferred.
• Clean room experience desirable.

Responsibilities

• Conduct GMP compliance walkthroughs and ensure procedures are followed.
• Perform real-time batch record reviews and assess impact on product quality.
• Review equipment logbooks and evaluate adjustments for quality impact.
• Develop, review, and revise procedures; assist CAPA investigations.
• Analyze data to identify corrective/preventive actions and drive process improvements.

Skills

GMP compliance

Quality mindset

Safety inspections

Data analysis

Education

Bachelor’s degree in Engineering

Job description

Otsuka ICU Medical LLC is seeking a Manufacturing Quality Engineer I to oversee GMP compliance in manufacturing operations and coach staff on quality and procedural standards. The role includes performing safety inspections, batch record reviews, and CAPA investigations.

The position requires a Bachelor’s degree in Engineering, 0-2 years of experience, and preferably prior pharma exposure. Clean room experience is desirable and travel is typically minimal.