Validation Specialist

Kelly Services; Arroyo (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Kelly Engineering is seeking a Validation Specialist for a contract position with a manufacturing client in Arroyo, Puerto Rico. The role focuses on TMV, IQ/OQ/PQ protocols, and supplier validations to ensure product quality and regulatory compliance.

You will analyze processes, design methods for inspection and testing, interact with suppliers and customer SMEs, and may train others in GMP/FDA-QSR topics. A background in validation runs and PPAPs is preferred.

Qualifications

• TMV (test method validation) required.
• Creation of SOPs and protocols for IQ/OQ/PQ.
• Documentation: IQ/OQ/PQ protocols and reports.
• Supplier process validations and PPAPs experience preferred.
• Execution of validation runs and training.
• Process development experience.”

Responsibilities

• Analyze assembly issues and identify effective solutions.
• Design and implement inspection, testing methods and procedures.
• Assess supplier designs and recommend fixtures and tools for quality at minimal cost.
• Prepare reports and documentation related to supplier processes.
• Interact with suppliers and SMEs on process changes and validation topics.
• Assist vendors in resolving manufacturing and quality issues; conduct/approve supplier validations.
• Potential involvement in new product introductions if applicable.

Skills

TMV (test method validation)

Creation SOPs

IQ/OQ/PQ protocols

Validation runs

Process development

New Product Introduction awareness

Job description

Kelly Engineering is seeking Validation Specialist for contract position at manufacturing client in Arroyo, Puerto Rico. If you’re passionate about bringing the latest professional discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring.

Continuously comply with all applicable regulations and industry standards.

Analyzes assembly issues and identify, test and implement the most effective solutions in a timely manner as result of supplier change requests

Responsible to stop further processing in the event of encountering non-conforming products condition.

Conducts analysis on variables within the unit (e.g. rework, scrap, etc.) and address recurring issues as appropriate.

Designs and/or implements methods and procedures for inspecting, testing, and evaluating the precision and reliability of products and/or production and/or test equipment, based on statistical process control, incoming part/product inspection criteria, automated testing, functional gauging, and productivity improvements.

Assess supplier’s proposed design, build and/or recommendation of fixtures, equipment and tools to ensure quality of our products, at minimal costs.

Develops or update reports and documentation related to suppliers processes (MAPs, MTRs, fixture database, etc.).

Comply with all safety and environmental standards applicable to the area.

Submits periodic reports on assigned topics to appropriate personnel.

May train others in Quality Assurance/GMP/FDA-QSR related topics, as a result of supplier changes

Interact with suppliers and Customer SMEs about process, material, specification changes, answer general product questions, develop and standardize inspection methods and or techniques to ensure components compliance with specifications. Assists vendors in resolving manufacturing and quality issues. Conduct, review or approve supplier validations related to process changes, materials, specifications, manufacturing transfer, etc. as applicable

May aid in the new product development process by identifying effective and efficient assembly techniques and manufacturing processes to be used.

Requirements

• TMV (test method validation)

• Creation SOPs

• Protocols and reports on IQ/OQ/PQ

• Supplier component process validations or PPAPs

• Execution of validation runs, training, etc

• Process development.

• Experience in New Product Introduction not required but if available is prefer.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. 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?

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 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.