Manufacturing Engineer (Equipment and Process Validation)
Contract Duration: 14 months - Estimated to end: 6/2027 ( Contract Extension possibilities and internal hire potential)
Location : 100% ONSITE - Irvine, CA (94538)
Type : W2 contract ( NO C2C OR THIRD PARTY will NOT be considered for this role )
Work Authorization: Must be currently in the United States with active employment authorization documents without CURRENT or FUTURE sponsorship transfer requirements. Sponsorship is NOT available NOW or in the FUTURE for this role.
Pay: Negotiable depending on direct-related experience up to $45 - $55 an hour
What Makes You Stand Out:
Experience planning, writing, and executing validation protocols (Installation, Operational, and Performance Qualifications) for equipment and processes in the medical device/pharma space.
Direct, in-depth experience supporting manufacturing in regulated environments (FDA, cGMP, ISO 13485).
Test Method Validations (TMV) and Gage R&R studies, ensuring measurement system reliability.
Managing CAPA, non-conformance, and deviation investigations, and are skilled at performing root cause analysis and implementing corrective actions for process/equipment issues. Proficient with risk management (FMEA, ISO 14971) and maintaining meticulous validation/quality documentation for audits and compliance.
Experience spans support for FDA, EU, and GMP regulatory expectations.
Experience with electronic documentation systems (e.g., LIMS, TrackWise, Veeva Vault, Windchill).
Job Summary:
Provides engineering support to a manufacturing process, project or function. Evaluates manufacturing outcomes and implements continuous improvements and cost efficiencies. Supports NPI and new equipment/process introductions.
Duties to include:
Tooling design and process development.
Ensure product and process quality by designing test methods, testing finished products and performing process capabilities studies.
Create and approve product drawings and documents.
Drive CAPA, root cause, and ensuring corrective/preventive measures stick.
End-to-end validation (especially equipment and process)
Establish and perform verification and validation activities including design verification testing, process and packaging validation and shelf-life studies.
Prepare product and process reports by collecting, analyzing and summarizing test data.
Evaluate and solve production problems.
Represent manufacturing in cross-functional meetings.
Ensure new equipment and tooling meet process validation requirements per established guiding procedures.
Target and implement cost reductions initiatives.
Train employees on current and new manufacturing processes.
Required:
Independent yet collaborative, who is comfortable in documentation-heavy, compliance-focused, and dynamic manufacturing settings. Reading and preparing technical documentation.
4+ years of expertise with medical device manufacturing equipment and processes.
Understanding of medical and technical development.
Experience working with ISO requirements, FDA regulations, medical device design control, and manufacturing scale-up processes.
Work Authorization: Must be currently in the United States with active employment authorization documents without CURRENT or FUTURE sponsorship transfer requirements. Sponsorship is NOT available NOW or in the FUTURE for this role.
Important information: To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.com.
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 (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly ® Engineering?
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About Kelly
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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.
