Validation Specialist (Pack Engineering Support)

Kelly Services; Añasco (PR); On-site; USD 28,000 - 40,000; Full time

Benefits offered by this job

Weekly pay (W2)

Sick, Vacations & Holidays paid

Christmas bonus

Job summary

Kelly Engineering in Puerto Rico is seeking a Validation Engineer to support sterile and non-sterile medical device packaging validation in a regulated manufacturing environment. The role requires a degree in engineering, GMP/ISO knowledge, and strong documentation skills.

It offers weekly pay and comprehensive benefits in a collaborative setting. The position emphasizes hands-on testing, protocol execution, cross-functional coordination, and continuous improvement within ISO-class environments.

Qualifications

• Bachelor's Degree in Engineering or related technical discipline (required).
• Internship, co-op, or academic project experience within medical devices, manufacturing, quality, or packaging is considered as experience
• Experience working in a regulated industry (Medical Device, Pharmaceutical, Biotechnology, etc.). Experience with tray-sealing processes (required).
• Available for working in ISO Class 7 cleanroom environments and following strict gowning requirements.
• Demonstrate strong documentation, organizational, and communication skills.
• Fluent in English (read, write, speak, and understand).
• Proficient in Microsoft Office (Excel, Word, PowerPoint).
• Thrive in a fast-paced, collaborative manufacturing environment with a strong willingness to learn.
• At least 4+ years of engineering or manufacturing experience. (Preferred)
• Experience with packaging validation, laboratory testing, or engineering projects.
• Knowledge of FDA QSR, ISO 13485, ISO 9001, GMP, and medical device regulations.
• Exposure to sterile barrier systems and validation methodologies.

Responsibilities

• Supporting packaging validation and testing activities for sterile and non-sterile medical device packaging systems.
• Executing validation protocols, engineering studies, and testing activities in close collaboration with Packaging and Project Engineers.
• Collecting, analyzing, and documenting testing data and validation results.
• Preparing and maintaining technical documentation, including protocols, reports, and test summaries.
• Coordinating with cross-functional teams such as Quality, Operations, Regulatory, and Engineering.
• Supporting troubleshooting, risk assessments, process improvements, and packaging line trials.
• Ensuring compliance with internal procedures and applicable regulatory requirements.

Skills

Fluent English

Education

Bachelor's Degree in Engineering

Tools

Microsoft Office

Job description

Think the best job opportunities are far away? Think again. Great opportunities are right here in your backyard.

Kelly® Engineering is looking for a Validation Engineering to work at a premier manufacturing client in Añasco, PR.

Let us help you grow at work and discover the next step in your career, all while being a vital part of your community.

Compensation : From $25 by hr and up, based on experience

Shift : Admin, Monday through Friday. Available weekends, alternate shifts, after-hours activities when needed

Location : On Site | Añasco, Puerto Rico

This job might be an outstanding fit if you have the following qualifications:

• Bachelor's Degree in Engineering or a related technical discipline (required).

• Internship, co-op, or academic project experience within medical devices, manufacturing, quality, or packaging is considered as experience

• Experience working in a regulated industry (Medical Device, Pharmaceutical, Biotechnology, etc.). Experience with tray-sealing processes (required).

• Available for working in ISO Class 7 cleanroom environments and following strict gowning requirements.

• Demonstrate strong documentation, organizational, and communication skills.

• Fluent in English (read, write, speak, and understand).

• Proficient in Microsoft Office (Excel, Word, PowerPoint).

• Thrive in a fast-paced, collaborative manufacturing environment with a strong willingness to learn.

• Preferred Requirements

• At least 4+ years of engineering or manufacturing experience.

• Experience with packaging validation, laboratory testing, or engineering projects.

• Knowledge of FDA QSR, ISO 13485, ISO 9001, GMP, and medical device regulations.

• Exposure to sterile barrier systems and validation methodologies.

What’s a typical day as Validation Engineering? You’ll be:

• Supporting packaging validation and testing activities for sterile and non-sterile medical device packaging systems.

• Executing validation protocols, engineering studies, and testing activities in close collaboration with Packaging and Project Engineers.

• Collecting, analyzing, and documenting testing data and validation results.

• Preparing and maintaining technical documentation, including protocols, reports, and test summaries.

• Coordinating with cross-functional teams such as Quality, Operations, Regulatory, and Engineering.

• Supporting troubleshooting, risk assessments, process improvements, and packaging line trials.

• Ensuring compliance with internal procedures and applicable regulatory requirements.

Why you should apply to be Validation Engineering:

• Opportunity to work in a regulated medical device manufacturing environment.

• Competitive pay rate with room to grow based on experience.

• Collaborate with engineering, quality, and regulatory professionals on impactful validation projects.

• Work for a respected industry leader focused on safety, compliance, and continuous improvement.

• Gain valuable hands-on experience in packaging validation and technical documentation.

• Access to the following benefits:

• Weekly pay (W2)

• Sick, Vacations & Holidays paid*

• Christmas bonus*

• • Must comply with minimum established requirements to qualify.

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. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

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 (https://www.kellyservices.com/hubfs/myKelly/Resources/Employment_Policies/Recruitment-Artificial-Intelligence-Notice.pdf?hsLang=en) .

Kelly Services is proud to be an Equal Employment Opportunity and Aff…