Validation Engineer

Job Description

Job Description

At  Kelly® Science, Engineering, Technology & Telecom (SETT) , we’re passionate about helping you find a job that works for you. How about this one?
We’re seeking a  Validation Engineer to work with one of our top global biopharmaceutical clients in the  Anasco, PR area. With us, it’s all about finding the job that’s just right

The Validation Engineer will support and execute validation activities for manufacturing processes, equipment, cleaning, and computerized systems in a regulated environment. The role ensures compliance with applicable regulatory requirements (FDA, ISO, cGMP) and internal quality standards. The ideal candidate has 2–5 years of experience in validation within the medical device, pharmaceutical, or similarly regulated industry.

Resposibilities

• Develop, execute, and document validation protocols and reports, including:
  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
• Support process validation activities 
• Participate in equipment qualification and requalification activities.
• Perform validation impact assessments for changes (Change Control/CN/CR).
• Collaborate with cross-functional teams (Manufacturing, Quality, R&D, Engineering, Regulatory).
• Ensure compliance with applicable regulations
• Analyze data using statistical tools (e.g., Minitab, Excel) to support validation conclusions.
• Assist in protocol deviations, investigations, and corrective actions
• Maintain accurate and complete documentation in accordance with GDP (Good Documentation Practices).
• Support audits and regulatory inspections by providing validation documentation.
• Track and report validation project status, timelines, and deliverables.

 

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 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.