
Description
Validation Engineer
Kelly Services is currently seeking a Validation Engineer position for one of our top clients in Jacksonville, FL.
- Kelly Outsourcing Consulting Group KellyOCG, a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Validation Engineer for a long-term engagement at one of our Global clients in Jacksonville, FL. This role is a full-time, fully benefited position.
- As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from.
- You'll also be eligible for paid time off, including holiday, vacation and sick/personal time.
- All KellyOCG employees receive annual performance reviews.
As a Validation Engineer placed with KellyOCG you will be responsible for the following:
- Analyze and test protocols to ensure a product and its manufacturing processes comply with strict regulatory and quality standards.
- This role is critical for verifying that devices are safe, effective, and reliable before they reach the market.
Core responsibilities:
- Carry out the testing and data collection activities defined in the validation protocols.
- This can involve both manual and automated testing in a lab or on the manufacturing floor.
Documentation and reporting:
- Prepare comprehensive validation reports detailing test results, including any deviations or non-conformances.
- This documentation provides a critical audit trail for regulatory purposes.
Regulatory compliance:
- Ensure all validation activities and documentation adhere to relevant industry standards and regulatory requirements, such as FDA 21 CFR Part 820 and ISO 13485.
Risk management:
- Participate in risk assessments, such as Failure Mode and Effects Analysis FMEA , to identify potential hazards and ensure that risk mitigations are verified and validated.
Cross-functional collaboration:
- Work with teams including R&D, Quality Assurance, Manufacturing, and Regulatory Affairs to develop new products, transfer processes to manufacturing, and resolve validation issues.
Skills and Qualifications
Education:
- A Bachelor's degree in an engineering discipline e.g., biomedical, mechanical, or electrical or a related field is typically required.
Experience:
- 0-5 years preferably medical devices or pharmaceuticals, with a focus on validation or quality assurance.
Technical writing:
- Excellent technical writing skills are essential for authoring clear, precise, and compliant validation documentation, including protocols and reports.
Regulatory knowledge:
- A strong understanding of quality systems and regulatory requirements, such as FDA 21 CFR 820, ISO 13485, and ISO 14971 Risk Management , is critical.
Analytical skills:
- The ability to analyze data, use statistical tools e.g., Gage R R, SPC , and identify process trends or anomalies is necessary.
Important information: This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.
Why Kelly®
The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG®) is one focus within the full array of Kelly Services® workforce solutions.
Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.
The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.
As a Kelly Services employee, you will have access to numerous perks, including:
- Vacation and sick pay
- Paid holidays
- 401(k) plan
- Group medical, vision, dental, life, and short-term disability insurance options
- Kelly Discounts on goods and services, auto and home insurance, and tuition at Kelly partner schools
- Kelly Learning Center offers free courses and trainings
- Weekly pay
About Kelly Services®
As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter.
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law.
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.
Find what's next with Kelly®.
As a worker today, it's up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what's next is what we're all about. We know what's going on in the evolving world of work—just ask the 440,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.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.
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