Manufacturing Engineer II (Process Expert)

Siegfried•Irvine, CA

5d•$105,000 - $120,000•Onsite

About The Position

This role is for a Manufacturing Engineer II (Process Expert) within a Contract Development and Manufacturing Organization (CDMO) team. The position supports the production of therapies that make a meaningful difference in patients' lives. The Manufacturing Engineer II will act as a key technical resource for production processes and manufacturing instrumentation, focusing on process optimization, equipment qualification, investigations, technology transfers, and continuous improvement initiatives across various operations including API, formulation, aseptic fill-finish, inspection, and packaging.

Requirements

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.

Nice To Haves

Experience with aseptic processing and fill-finish operations, including equipment preparation, formulation, sterile filtration, and filling.
Experience supporting API manufacturing, sterile manufacturing, or commercial pharmaceutical production.
Prior aseptic fill-finish experience is preferred and will provide a strong foundation for success in this role due to the cross-functional support provided across sterile manufacturing operations.

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.