Job Information
Kelly Services Project Validation Specialist in Anasco, Puerto Rico
At Kelly ® Science & Engineering we’re passionate about helping you find a job that works for you. How about this one?
We’re seeking Project Validation Specialist to work with one of out top pharmaceutical/biotechnology industry clients at Añasco, PR. With us, it’s all about finding the job that’s just right.
Requirements:
Bachelor's Degree in Engineering, Microbiology or similar discipline.
Minimum of 5-7 years of experience in the medical device and/or pharmaceutical manufacturing environment with effective experience and knowledge in sterilization processes..
Hands-on experience with EU MDR or MDD remediation projects, compliance projects and process validation required.
Experience interpreting and applying standards and regulations to medical device microbiological and sterility assurance control programs for the purposes of interpreting data, tactical planning on a daily basis, implementing procedures, and remediation projects.
Experience in Ethylene oxide sterilization validation and requalification; Bacterial endotoxin test method validation and monitoring; Bioburden test method validation and monitoring; Reusable Medical Devices; Radiation sterilization validation and dose audit management; Controlled environment monitoring
Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
Excellent written and verbal communication skills and a strong track record of working cross-functionally. Bilingual ( Spanish and English)
The Project Validation Specialist will be responsible for provide support to Corporate / Division Sterilization Workstream to ensure efficient and timely completion of project deliverables related to sterilization area including, but not limited to new Ethylene oxide sterilization cycle validation, existing Ethylene oxide sterilization cycle re-validation, and sterilization cycle improvements
Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry—even if this position doesn’t work out, you’re still in our network. That means all our recruiters will have access to your profile, expanding your opportunities even more. Helping you discover what’s next in your career is what we’re all about, so let’s get to work.
Kelly ® Science & Engineering PR Offers!
Exposure to a variety of career opportunities as a result of our expansive network of client companies
Career guides, information and tools to help you successfully position yourself throughout every stage of your career
Access to more than 3,000 online training courses through our Kelly® Learning Center
Weekly pay by W-2
Vacations, Sick & 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. 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 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. 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 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.