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
· Bachelor of Science in Engineering Discipline (Mechanical/Chemical/Industrial Engineering) or Biological Science
· 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.)
City of Industry, California