Validation Engineer

Kelly Services; United States; On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Medical, dental, vision

Retirement savings plan

Paid holidays

Transit benefits

Job summary

Kelly is seeking a Validation Engineer to support manufacturing processes, equipment, and computerized systems in a regulated setting in Anasco, PR. The role emphasizes FDA/ISO compliance and GDP documentation.

Ideal candidates have 2–5 years of validation experience in pharma/medical devices and will work with cross-functional teams to ensure quality and regulatory adherence.

Qualifications

• 2–5 years of validation experience in a regulated industry (medical device/pharma).
• Experience executing IQ/OQ/PQ validation protocols.

Responsibilities

• Develop, execute, and document validation protocols and reports (IQ/OQ/PQ).
• Support process validation activities.
• Participate in equipment qualification and requalification.
• 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 to support conclusions.
• Assist in protocol deviations, investigations, and CAPAs.
• Maintain documentation per GDP.

Skills

Statistical reasoning

Quality compliance

Tools

Minitab

Excel

Job description

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.

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.