Process Engineer II - GMP Manufacturing Expert

Siegfried; Irvine (CA); Hybrid; USD 105,000 - 120,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Flexible Spending & HSA Options

Life Insurance

Short & Long Term Disability

Pet Insurance

Generous PTO

401K

Job summary

Siegfried is hiring a Manufacturing Engineer II (Process Expert) to support API, formulation, aseptic fill-finish, and packaging operations within a GMP environment. You will drive process optimization, equipment qualification, investigations, and technology transfers across the production spectrum.

The role focuses on owning production instrumentation, IQ/OQ/PQ activities, and writing critical technical documentation while mentoring manufacturing personnel and collaborating across

Qualifications

• Bachelor's degree in Engineering, Biological Sciences, or a related technical discipline.
• 3+ years of experience supporting pharmaceutical, biotechnology, biologics, cell and gene therapy, or CDMO manufacturing operations in a GMP-regulated environment.
• Experience qualifying equipment and manufacturing processes in a regulated manufacturing environment.
• Strong technical writing, data analysis, troubleshooting, and problem-solving skills.
• Working knowledge of GMP regulations, quality systems, and data integrity requirements.
• Demonstrated ability to manage multiple priorities in a fast-paced manufacturing environment.
• Strong communication and collaboration skills with the ability to influence and work effectively across cross-functional teams.

Responsibilities

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

Skills

Technical writing

Data analysis

Troubleshooting

Problem-solving

Communication

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Biological Sciences

Job description

Siegfried is hiring a Manufacturing Engineer II (Process Expert) to support API, formulation, aseptic fill-finish, and packaging operations within a GMP environment. You will drive process optimization, equipment qualification, investigations, and technology transfers across the production spectrum.

The role focuses on owning production instrumentation, IQ/OQ/PQ activities, and writing critical technical documentation while mentoring manufacturing personnel and collaborating across