Job Summary

 

Process Engineer (Level 3) with emphases in product, process and equipment understanding and improvement.   The job requires the individual to be hands on, motivated self-starter, work with cross functional teams, strong initiative and setting up new initiatives, programs, procedures and scorecards.  Responsible for process improvement to deliver primary manufacturing and/or R&D objectives that include but not limited to safety, compliance, productivity, cycle time, yield, output rates, etc. 

 

Primary Duties and Responsibilities

 

·       Manage critical capital expansion projects for process efficiency, including vendor selection, requirement specification, and IOPQ.

·       Design and prepare procedures, including protocols and reports, for material and technology evaluation, as well as for process improvement and equipment qualification,

·       Perform studies in pilot plant or full production scale by following written instruction (equipment setup, data collection, sample submission, sample testing, and others)

·       Identify and qualify alternate production supplies to reduce production cost.

·       Implement major process, equipment and material changes through Change Control and Document Change Request processes, including the preparation of regulatory submission supporting documents.

·       Perform analysis using a statistical software (Minitab) to understand and interpret data, and write summary and technical reports.

·       Lead and facilitate technical problem solving session with cross-function team through various DMAIC tools.

·       Provide technical solution to engineering team for R&D projects or continuous improvement ideas, assist validation engineer on process validation.

Job Requirements and Qualifications

 

Educational Preference

 

·       Bachelor of Science in Engineering Discipline (Mechanical/Chemical/Industrial Engineering) or Biological Science

Experience Preference

 

·       5 to 9 years in an engineering or biological related field

·       Knowledge of cGMP and cleanroom system is a must

·       Basic knowledge of Six Sigma, DMAIC or Lean principles Knowledge of equipment design and  operating principals

·       Hands-on experience with process tanks, continuous separators, ultrafiltration, chromatography, pumps in pilot plant or manufacturing environment

·       Hands-on experience in continuous improvement project leadership

·       Strong PC skills with MS Words, Excel, PowerPoint, Visio, Project, Minitab

Other Knowledge, Skills and Abilities

 

·       Strong technical understanding of filtration/ultrafiltration process

·       Strong understanding of equipment design and operation.

·       Positive attitude and motivated Self Starter

·       Working independently with minimal supervision

·       Capable of self-generating and implementing value improvement projects

·       Produce and present clear, concise and professionally written communications and presentations

·       Must be able to work under pressure, meet deadlines, and be flexible when working on multiple projects simultaneously

·       Strong Continuous Improvement and Troubleshooting mindset

·       Capable of making quick and sound decisions

·       Results oriented

·       Good interpersonal skills

o   Candidate will work with production personnel, supervisors and managers

Work Environment (Location, travel, shift, on-call, etc.)

 

Travel

 

<5%

 

Location

 

City of Industry, California