Search Jobs

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, )
Apply Online
Apply with LinkedIn Apply with Facebook Apply with Twitter
Chat With A Recruiter

Send an email reminder to:

Refer A Friend

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

All Testimonials

John understood the scope of my job and was able to manage my moving goal posts and did not get rattled when I pulled the carpet out from under him …Read More

Bill M.

See All Testimonials

PEAK Careers!

Take control of your career! Join the team as a recruiter at PEAK and build the future of your dreams.