Job Description
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. As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Why Kelly® Engineering? Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career. About Kelly Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life-just ask the 300,000 people we employ each year. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.
