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Sr. Process Engineer

Irvine, CA 92618

Posted: 07/23/2019 Employment Type: Direct Placement Category: Engineering Technicians, Except Drafters Job Number: 82725

The Sr. Process Engineer is responsible for the development, improvement, validation, and support of semi-automated/fully automated manufacturing processes for production of biochemical products. Scope of responsibility included specifying, procuring, qualifying, troubleshooting, and maintaining equipment needed for processes for mixing, dispensing, and/or packaging biochemical components and/or products. May also be responsible for introducing new manufacturing technologies to support existing manufacturing processes and equipment; addresses daily technical issues and challenges in production and operations. May lead and/or support technology transfers to international or external manufacturing plants. Initiate continuous improvement opportunities utilizing methodologies; such as Lean/Six Sigma, DFM, SPC, etc. Follows domestic and international regulatory standards (e.g., GMP and ISO 13485).


Here’ s where you’ ll demonstrate your competencies:
  • Develop process windows/limits for manual and automated production processes;
  • Perform process validations as required, IQ/OQ/PQ; generate protocols and test reports;
  • Respond to and solve daily technical issues in Irvine manufacturing;
  • Disposition Non-conforming materials, determine root cause, and implement corrective action;
  • Act as technical liaison between R&D Engineering and Manufacturing,
  • Design, develop, implement, and improve manufacturing processes and equipment
  • Introduce best in class manufacturing technologies to Irvine operations
  • Create user-friendly, pictorial based manufacturing procedures with users in mind
  • Train lab technicians, and manufacturing operators on processes and procedures
  • Develop, implement, and support Lean processes in production and throughout operations;
  • Lead/support continuous improvement projects and initiatives;
  • Troubleshoot production line issues and customer complaints related to yield, quality, and throughput. Implement the appropriate robust containments and corrective actions on identification of root cause.
  • Develop Process Failure Mode and Effects Analyses;
  • Support supplier qualifications and assist in new supplier selection process;
  • Continuously research, learn, and recommend best practices for world-class manufacturing;
  • Maintain training records and always follow operating procedures;


Minimum Requirements:
  • B.S./M.S./PhD in Engineering discipline, Chemical Engineering, Biochemical Engineering, Bioengineering, Bio-Medical, or MS/PhD in relevant scientific field with at least 4 years of experience in manufacturing, process development and characterization, process design and scale-up, improvement and validation.
  • Experience with processing, dispensing, and packaging of biochemical products
  • Experience working in bio-chemical laboratory and with general lab equipment
  • Experience with Process Validation (IQ/OQ/PQ) and able to generate protocols and test reports
  • Experience and ability to troubleshoot simple to complex manufacturing process issues
  • Excellent conceptual, analytical, and problem-solving ability
  • Experienced and skilled with data analysis including the use of statistical tools such as Minitab
  • Excellent communication skills, both verbal and written, and the ability to effectively interface within a cross-functional teams.
  • Skilled with CAD modeling software such as SolidWorks
  • Experience working in an ISO13485, GMP, or FDA regulated environment is desirable.
  • Experience with continuous improvement methodologies (ie, Lean, Six Sigma, OEE, )
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