GMP Manufacturing Engineer II – Process Expert & Optimizer

Alliance Medical Products, Inc.

Irvine (CA)

On-site

USD 105,000 - 120,000

Full time

5 days ago

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Benefits offered by this job

Medical

Dental

Vision

Flexible Spending & HSA Options

Life Insurance, Disability

Job summary

Siegfried is seeking a Manufacturing Engineer II (Process Expert) to support GMP pharmaceutical manufacturing across API, formulation, aseptic fill-finish, inspection, and packaging. You will optimize processes, qualify equipment, manage investigations, and lead continuous improvement initiatives, partnering with Quality, Engineering, and Manufacturing teams.

The role emphasizes technical ownership of production instrumentation, calibration, and documentation, with opportunities to influence

Qualifications

Bachelor's degree in Engineering or related field.
3+ years in GMP pharmaceutical manufacturing.
Experience qualifying equipment and processes (IQ/OQ/PQ).
Strong writing, data analysis, troubleshooting skills.
Familiarity with GMP regulations, quality systems, and data integrity.

Responsibilities

Provide technical support for GMP pharmaceutical manufacturing operations.
Own and maintain manufacturing documentation (SOPs, Master Batch Records, protocols).
Lead or support equipment qualification activities (IQ/OQ/PQ) and process validations.
Serve as technical owner for production instrumentation (calibration, maintenance, repair).
Lead investigations and root-cause analyses for manufacturing events.
Collaborate cross-functionally to ensure compliant and reliable operations.
Support process optimization and introduction of new technologies.