Job Description

**cGMP Compliance Engineer** **Location:** Yorba Linda, CA **Job Type:** Contract-to-Hire (Monday-Friday, with OT availability) **Pay Rate:** $50/hr - $60/hr (flexible for highly qualified candidates) **About the Opportunity** Kelly Engineering is seeking a **cGMP Compliance Engineer** to join a leading medical device manufacturing company. This role focuses on ensuring compliance with FDA regulations, ISO 13485 standards, and cGMP requirements. If you are passionate about driving quality and compliance in manufacturing processes and have a track record of success in regulated environments, this opportunity is for you. **Why Join Us?** + **Innovative Work:** Contribute to the development of cutting-edge medical devices. + **Career Growth:** Opportunity for long-term employment through a contract-to-hire structure. + **Competitive Pay:** Negotiable rates for exceptional candidates. + **Work-Life Balance:** Standard weekday schedule with overtime options for flexibility. **Key Responsibilities** + Revalidate chemical, electrochemical, laser, and cleaning systems, as well as assembly processes in cleanroom environments. + Lead the validation lifecycle, including risk assessments, deviation investigations, and change control activities. + Author and manage protocols (IQ, OQ, PQ) and summary reports while adhering to cGxP standards. + Identify and mitigate risks proactively to enhance operational efficiency. + Collaborate with cross-functional teams on requirements and project timelines. + Contribute to training and continuous improvement initiatives. + Support investigations, CAPA processes, and quality system audits to ensure compliance. **Qualifications** + **Education:** Bachelor's degree in engineering or a related science field is required (Master's preferred). + **Experience:** Minimum of 5 years in a cGMP manufacturing environment. + **Expertise:** + ISO 13485 Medical Device standards. + Strong cGxP knowledge, including process validation and qualification. + Experience in pFMEA development and statistical process control (SPC). + Familiarity with ISO Class 7 cleanrooms and equipment qualification. + **Skills:** + Technical writing for cGxP documentation. + Ability to drive results in regulated environments. + Effective communication and teamwork capabilities. **Ready to make an impact in the medical device industry?** Apply now to join a team dedicated to quality and innovation.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. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's 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.

Job Tags

Contract work, Temporary work, Long term contract, Local area, Flexible hours, Weekday work, Monday to Friday,

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