Process Engineer II: GMP Pharma Process & Tech Transfer

Alliance Medical Products, Inc.; Irvine (CA); On-site; USD 115,000 - 130,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Flexible Spending & HSA Options

Life Insurance

Short- & Long-Term Disability

Pet Insurance

Generous PTO

Sick & Holiday Time Off

401K

Job summary

Siegfried in Irvine, CA, is seeking a Process Engineer II to support pharmaceutical process development, technology transfers, and commercial manufacturing within MS&T. You will plan, execute, and interpret studies to drive continuous improvements and scale-up on site.

The role requires solid GMP knowledge for parenteral products, experience with DoE, CAPAs, deviations, and collaboration with QA, Project Management, and Manufacturing. Competitive salary and comprehensive benefits available.

Qualifications

• Bachelor’s degree with six years’ experience or Master’s with four years in industry.
• Minimum three years in Fill/Finish or Aseptic Process operations in GMP.
• Minimum three years taking equipment/process from development to GMP readiness.
• Equivalent education or experience may substitute.

Responsibilities

• Own knowledge of manufacturing process technologies for scale-up, DoE, and CPP/CQAs.
• Contribute to manufacturing procedures and SOPs for new processes.
• Support process validation studies and data/trend analysis.
• Improve robustness/capability of processes using statistical analysis.
• Own deviations, CAPAs, and audit responses.
• Assist on-the-floor troubleshooting and root-cause investigations.
• Develop client presentations and evaluate project feasibility.
• Train and mentor junior MS&T members and operators.

Skills

GMP manufacturing

Process development

risk-based decision making

cross-functional teams

root cause analysis

problem solving

communication with clients

GMP IT systems knowledge

Education

Bachelor’s degree in Engineering or science-related field

Master’s degree in Engineering or science-related field

Tools

SAP

LIMS

Job description

Siegfried in Irvine, CA, is seeking a Process Engineer II to support pharmaceutical process development, technology transfers, and commercial manufacturing within MS&T. You will plan, execute, and interpret studies to drive continuous improvements and scale-up on site.

The role requires solid GMP knowledge for parenteral products, experience with DoE, CAPAs, deviations, and collaboration with QA, Project Management, and Manufacturing. Competitive salary and comprehensive benefits available.