Demo

Process Engineer II

BioPhase
Orange, CA Full Time
POSTED ON 3/3/2025
AVAILABLE BEFORE 5/21/2025

BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Process Engineer II to work for a leading Greater Orange County area contract development and manufacturing organization.

Salary : $110,000-120,000 / year (depending on experience)

Summary :

The Process Engineer II provides the site with knowledge and expertise required to support the company's diverse portfolio including process development, tech transfers, and commercial products. They will oversee implementation of new technologies by designing, planning, executing, and interpreting scientific reports and experiments to contribute to the overall success of the organization. They will also play a role in continuous process improvements and innovation for the site. This position requires a high level of proficiency in late-stage process development or clinical / commercial manufacturing operations.

Responsibilities :

  • Participate in the creation of manufacturing procedures and SOPs for new processes and products. Own and support process validation studies and the data / trend analysis.
  • Responsible for the robustness and capability of the manufacturing processes developed using statistical analysis to create and monitor Critical Process Parameters (CPPs) and Critical Quality Attributes (CQAs)
  • Own deviations, CAPAs, and audit responses. Support on-the-floor troubleshooting and root-cause investigations.
  • Develop potential clients' presentations and proposal generations including project evaluations and technical feasibility assessments.
  • Build scientific knowledge and increase technical know-how within and beyond the MSAT department.
  • Provide technical training and mentorship to junior MSAT members and manufacturing operators.

Experience / Requirements :

  • 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.
  • Experience with root cause analysis and product quality impact assessments for deviations and investigations utilizing Lean and Six Sigma tools.
  • Working knowledge of risk-based decision making and stage-appropriate implementation strategies supporting clinical manufacturing, technology transfers, and commercial manufacturing.
  • Working knowledge of GMP production-related IT systems such as SAP and LIMS is a plus
  • Capable of working with global and cross-functional teams in dynamic and time-bound environments while building effective working relationships across departments to support the introduction of new processes and products.
  • Capable of identifying issues, providing solutions, and forward thinking through solid problem solving.
  • Able to effectively communicate with internal and external clients on matters concerning technical feasibility and GMP readiness.
  • Salary : $110,000 - $120,000

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