Pharma Manufacturing Engineer II - Process Expert

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

Benefits offered by this job

Medical, Dental, Vision

Flexible Spending & HSA

Life Insurance

Short & Long Term Disability

Pet Insurance

Generous PTO

401K

Job summary

Siegfried is seeking a Manufacturing Engineer II (Process Expert) for our Irvine, CA site to optimize production, qualify equipment, and drive continuous improvement in GMP environments. You will support API, aseptic, fill-finish, and packaging operations while partnering with cross-functional teams across Quality, Engineering, and Manufacturing.

Ideal candidates have a strong background in pharma manufacturing, documentation ownership, and a proven track record of leading investigations and

Qualifications

• Bachelor's degree in Engineering, Biological Sciences, or related technical discipline.
• 3+ years' 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 cross-functional teams.

Responsibilities

• Provide technical support for GMP pharmaceutical manufacturing operations.
• Own and maintain critical manufacturing documentation (SOPs, Master Batch Records, protocols, risk assessments, investigations, reports).
• Lead or support equipment qualification activities (IQ/OQ/PQ), process validations, and continuous improvement projects.
• Serve as 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 with Manufacturing, Quality, Engineering, and other stakeholders to ensure compliant operations.
• Support process optimization, implementation of new technologies, and introduction of new products.
• Maintain inspection readiness and 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

GMP regulations

Quality systems

Data integrity

cross-functional collaboration

multi-priority management

Education

Bachelor's degree in Engineering/Biological Sciences or related technical discipline

Tools

IQ/OQ/PQ

Job description

Siegfried is seeking a Manufacturing Engineer II (Process Expert) for our Irvine, CA site to optimize production, qualify equipment, and drive continuous improvement in GMP environments. You will support API, aseptic, fill-finish, and packaging operations while partnering with cross-functional teams across Quality, Engineering, and Manufacturing.

Ideal candidates have a strong background in pharma manufacturing, documentation ownership, and a proven track record of leading investigations and