Job Summary

 

Process Engineer II is a technical role with emphases in product and process understanding and process improvement. The job requires the individual to be a hands-on motivated self-starter, work with cross functional teams, have strong initiative, and set up new programs and procedures. The individual is responsible for process improvement to deliver manufacturing and/or other technical objectives that include but are not limited to safety, compliance, productivity, cycle time, yield, output rates, reliability, etc.

 

Primary Duties and Responsibilities

 

·         Service as technical engineering resource in support of Manufacturing department in areas of Bulk, Filling, and Packaging processes.

·         Interface with process and facility maintenance groups to support process equipment and critical systems uptime.

·         Engage in hands-on equipment troubleshooting (mechanical/electrical/controls).

·         Develop and prepare technical documentation (eg. studies, protocols, and reports) for material and technology evaluation, process improvement, and equipment qualification.

·         Execute studies by following written instruction (eg. equipment setup, data collection, sample submission, sample testing, and others).

·         Implement material, equipment, and process  changes through Change Control and Document Change Request processes

·         Coordinate and execute equipment Factory Acceptance Test at vendor sites.

·         Coordinate and execute equipment installation, Site Acceptance Test, and engineering commissioning.

·         Execute equipment Installation, Operational and Performance Qualification.

·         Provide tactical support of manufacturing process/product non-conformances and develop technical solutions to resolve issues.

·         Lead technical problem solving sessions with cross-function team to achieve Lean and efficient resolutions to manufacturing issues.

·         Utilize DMAIC methodology in process improvement projects.

·         Track and evaluate the yield performance of manufacturing process.

·         Perform analysis using statistical software (eg. Excel, Minitab) to understand and interpret data, and present technical conclusions.

·         Provide technical solutions to R&D department for projects or continuous improvement ideas.

·         Provide technical support to Validation department for Process Performance Qualifications.

 

Job Requirements and Qualifications

 

Educational Preference

 

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

 

Experience Preference

 

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

·         Knowledge of cGMP and experience working in cleanroom systems is a must

·         Basic knowledge of Six Sigma, DMAIC, and Lean principles

·         Knowledge of automated manufacturing equipment design and operating principals

·         Knowledge of equipment emergency, preventative, and corrective maintenance strategies

·         Knowledge of equipment and process qualification strategies

·         Hands-on experience with process tanks, mixers, separators, ultrafiltration, liquid processing, and process automation in a manufacturing environment

·         Hands-on experience in continuous improvement project leadership

·         Strong PC skills with MS Office Suite, Minitab

 

Other Knowledge, Skills and Abilities

 

·         Positive attitude and motivated self-starter

·         Ability to work independently with minimal supervision

·         Capable of independently identifying and implementing value improvement projects

·         Produce and present clear, concise, and professional 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 and justifying quick and sound decisions

·         Results oriented

·         Excellent 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

 

Physical Requirements

 

a.    Activities. How much on-the-job time is spent in the following physical activities? Show the amount of time by checking the appropriate boxes below.

 

Amount of Time
Activity	None	Up to 1/3	1/3 to 2/3	2/3 or more
Stand		X
Walk		X
Sit			X
Talk or hear		X
Use hands to finger, handle or feel			X
Climb or balance		X
Stoop, Kneel, crouch or crawl		X
Reach with hands and arms		X
Taste or smell	X

 

b.    Lifting. Does this job require that weight be lifted or force be exerted? If so, how much and how often? Check the appropriate boxes below.

 

Amount of Time
Activity	None	Up to 1/3	1/3 to 2/3	2/3 or more
Up to 10 pounds				X
Up to 25 pounds		X
Up to 50 pounds		X
Up to 100 pounds		X
More than 100 pounds		X

 

Direct Reports

 

N/A