Pharma Manufacturing Engineer II: Process Excellence

Siegfried AG; Irvine (CA); On-site; USD 105,000 - 120,000; Full time

Job summary

Siegfried AG in Irvine, CA is seeking a Manufacturing Engineer II (Process Expert) to drive process optimization, equipment qualification, and continuous improvement across API, formulation, aseptic fill-finish, and packaging operations. You will be a key technical resource supporting GMP pharmaceutical manufacturing.

This role requires a Bachelor's in Engineering or related field and 3+ years GMP experience, with strong technical writing and cross-functional collaboration across Manufacturing,

Qualifications

• Bachelor's degree in Engineering, Biological Sciences, or related technical discipline.
• 3+ years of GMP pharma/manufacturing ops experience.
• Experience qualifying equipment and processes in a regulated environment.
• Strong technical writing, data analysis, troubleshooting and problem-solving skills.
• Working knowledge of GMP regulations, quality systems, and data integrity requirements.
• Ability to manage multiple priorities in a fast-paced manufacturing environment.

Responsibilities

• Provide technical support for GMP pharmaceutical manufacturing operations.
• Own and maintain SOPs, Master Batch Records, protocols, risk assessments, investigations, and technical reports.
• Lead or support IQ/OQ/PQ, process validations, and continuous improvement projects.
• Serve as the technical owner for production instrumentation, including calibration and preventive maintenance.
• Lead investigations, root cause analyses, and corrective actions related to manufacturing events.
• Partner cross-functionally with Manufacturing, Quality, Engineering, and other stakeholders.
• Support process optimization, implementation of new technologies, and introduction of new products.
• Maintain inspection readiness and ensure GMP, FDA, safety, and environmental compliance.
• Provide technical guidance and training to manufacturing personnel.
• Support manufacturing operations directly as business needs require.

Skills

Technical writing

Data analysis

Troubleshooting

Problem solving

Cross-functional collaboration

Communication

Education

Bachelor's degree in Engineering

Job description

Siegfried AG in Irvine, CA is seeking a Manufacturing Engineer II (Process Expert) to drive process optimization, equipment qualification, and continuous improvement across API, formulation, aseptic fill-finish, and packaging operations. You will be a key technical resource supporting GMP pharmaceutical manufacturing.

This role requires a Bachelor's in Engineering or related field and 3+ years GMP experience, with strong technical writing and cross-functional collaboration across Manufacturing,