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Company

Original Job Post

Siegfried · 2 days ago

Senior Process Engineer

Irvine, CA

Full-time

Onsite

Senior Level

$125K/yr - $140K/yr

8+ years exp

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Responsibilities

Lead technology transfers and oversee the transfer of processes and technologies from process development to GMP manufacturing

Evaluate new processes, technologies, methods, and materials to deliver customer needs and GMP products

Develop manufacturing procedures, SOPs, and support process validation studies

Monitor Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs) using statistical analysis

Handle deviations, CAPAs, audit responses, troubleshooting, and root-cause investigations

Create client presentations, proposals, and conduct project evaluations

Qualification

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GMP ManufacturingProcess DevelopmentQuality AttributesManufacturing ControlsRisk-Based Decision MakingTechnology TransfersRoot Cause AnalysisLean Six SigmaProduct Quality Impact AssessmentsSAPLIMSFill/Finish OperationsAseptic Process OperationsEquipment Bring-upOperational ReadinessPharmaceuticalsBiologicsProblem-SolvingVerbal CommunicationSelf-AwarenessDecision MakingLeadership

Required

Strong understanding and hands-on experience in GMP manufacturing or process development of parenteral products, including the quality attributes and manufacturing controls for pharmaceuticals or biologics.

Proven expertise in risk-based decision making and stage-appropriate implementation strategies supporting clinical manufacturing, technology transfers, and commercial manufacturing.

Proven ability to lead root cause analysis and product quality impact assessments for deviations and investigations utilizing Lean and Six Sigma tools.

Highly capable of identifying issues, providing solutions, and forward-thinking through solid problem-solving.

Excellent verbal communication, oral presentation, self-awareness, and the impact of communication and its working style on others.

Advance use of GMP production-related IT systems such as SAP and LIMS desired.

Bachelor's Degree in Engineering or science-related field with eight years of industry experience or Master's degree with six years of industry experience.

Minimum three years of experience in Fill/Finish or Aseptic Process operations, preferably in clinical or commercial GMP manufacturing.

Minimum three years of experience bringing pharmaceutical equipment, process, or methods from development to GMP operational readiness.

Equivalent education or experience may substitute the stated requirements.

Company

Siegfried

Expect more with Siegfried as your preferred partner. Siegfried is a preferred manufacturing and service partner in the global pharmaceutical industry.

Founded in 1873

Zofingen, Aargau, CHE

1,001-5,000 employees