Process Engineer

Process Engineer Apply Now Applied To save a job sign in or get started

Job ID:

10231913 Posted today Back Yorba Linda, CA, US Engineering Bachelors Degree Full Time, Temporary $45

• 50/hr. Experienced (Non-Manager) On-site Manufacturing
• Other First Shift (Day) Yorba Linda, CA, US $45
• 50/hr. Experienced (Non-Manager) Full Time, Temporary Manufacturing
• Other On-site Engineering Bachelors Degree First Shift (Day) Apply Now Applied Job details Process Engineer

•

Equipment Qualification & Process Validation Location:

Yorba Linda, CA Schedule:

100%

Onsite Duration:

1

Year Contract Pay Rate:

$45

• 50/hr DOE Kelly Engineering is seeking a Process Engineer with strong equipment qualification and process validation experience to support a regulated manufacturing environment.

This role will focus heavily on IQ/OQ/PQ, validation documentation, manufacturing support, and cross-functional engineering collaboration. Responsibilities Lead equipment qualification activities including

URS/DQ, IQ/OQ/PQ

Execute process validation (PV) activities and validation strategy development Author validation protocols, reports, deviations, and technical documentation Support FAT/SAT, commissioning, installation, and manufacturing readiness Define CPPs, CQAs, process windows, and acceptance criteria Support PFMEA, risk assessments, change controls, and CAPA activities Troubleshoot manufacturing and equipment issues using root cause analysis Maintain validated state of manufacturing equipment and processes Support continuous improvement initiatives related to quality, yield, uptime, and reliability Required Qualifications Bachelor's degree in Engineering or equivalent experience 5+ years of Process Engineering or Manufacturing Engineering experience Strong experience with:

IQ/OQ/PQ

Process Validation Equipment Qualification Validation Protocols & Reports GMP/regulated manufacturing environments Root Cause Analysis Technical Documentation Change Control Risk Management/PFMEA Medical device industry experience preferred Pharma validation experience acceptable Experience with ISO 13485 and GMP concepts preferred Experience with DOE/statistical analysis preferred Experience with SAP or electronic documentation systems preferred Experience supporting manufacturing floor operations required Additional Notes Candidates must be comfortable working independently with minimal supervision Strong documentation and technical writing skills are critical for success in this role Some domestic travel may be required for FAT/SAT or supplier support activities Kelly Engineering is an equal opportunity employer. 10231913 Share this job Copied url To save a job sign in or get started To apply for this job email your details to I want more jobs like this in my inbox.

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