Process Engineer – GMP Manufacturing & Optimization

Otsuka Pharmaceutical Co., Ltd; San Fernando (CA); On-site; USD 80,000 - 133,000; Full time

Job summary

Pharmavite seeks a Process Engineer to optimize dosage forms, establish process controls, and provide cross-functional technical support. The role emphasizes data-driven improvements and alignment with GMP standards to maximize product reliability and customer value.

You will develop process understanding, lead CAPAs, and participate in QCRs and validation protocols, while collaborating with manufacturing, QA, and facilities teams.

Qualifications

• Bachelor's degree in engineering or related field.
• 4-6 years in relevant industry with at least two years in pharma/nutrition/CPG.
• 1-3 years in manufacturing technical support or process/product development/quality engineering/testing.

Responsibilities

• Optimize products and processes; establish guardrails for repeatability.
• Prepare and review technical docs (MBRs, QC reports, SOPs, change controls).
• Support FAT/SAT/PQ, IQ/OQ activities and equipment qualification.
• Lead cross-functional teams to drive improvements and maintain GMP compliance.

Skills

Process development

Regulatory knowledge

Lean manufacturing

Cross-functional collaboration

Education

Bachelor's degree in Industrial/Mechanical/Chemical Engineering or related

ASQ Certified Quality Engineer

Certified Packaging Professional / Six Sigma (plus)

Tools

DOE

QbD

GMP knowledge

Job description

Pharmavite seeks a Process Engineer to optimize dosage forms, establish process controls, and provide cross-functional technical support. The role emphasizes data-driven improvements and alignment with GMP standards to maximize product reliability and customer value.

You will develop process understanding, lead CAPAs, and participate in QCRs and validation protocols, while collaborating with manufacturing, QA, and facilities teams.