Material Scientist Job Listing at Kelly Services in Arroyo (Job ID US3532077_BH9721391)

Description

At Kelly® Science, Engineering, Technology & Telecom (SETT), we're passionate about helping you find a job that works for you. We're seeking an Staff Scientist to work with one of our top global biopharmaceutical clients in the Arroyo, PR area. With us, it's all about finding the job that's just right. 
Position Summary
The Staff Scientist will be responsible for providing technical support / execution to various areas of the business including biocompatibility, cleaning, disinfection, and sterilization process of medical devices.
Technical Responsibilities:

• Lead development of compliant testing protocols and guidelines and support business for new product development, product changes and sustaining of sterilized medical devices.
• Plan, develop, execute and complete sterilization validation according to business needs.
• Support Business Development/Acquisition reviews as an SME, as needed.
• Independently coordinate, execute and complete project deliverables in collaboration with cross functional groups such as R&D, Global Quality Operations (GQO), Regulatory, and Marketing.
• Interpret, assess, analyze and apply international standards related to sterilization, cleaning, disinfection and biocompatibility. 
• Provide solutions to a wide range of technical problems of significant scope and complexity; independently determine and develop approach to solutions. This may include support for quality issues such as customer complaints, adverse events, product field actions, and non-conformances.  Advise junior SMEs.
• Perform gap assessments to new or changing standards and mentor others.
• Lead the development or revision of quality system procedures, as needed. This may include serving as a divisional process owner (DPO).
• Support internal and external regulatory audits as an SME.
• Participate in Corporate wide projects or initiatives; this may include corporate quality system workgroups.
• Apply and mentor others on advanced technical principles, regulations, and concepts.
• Lead responses to internal and external customer inquiries.

  EDUCATION REQUIREMENTS

• Bachelor of Science in Biology, Microbiology, Chemistry, or Biomedical Engineering.

5v+ years of work experience
Technical Skills:

• Thorough technical knowledge and understanding of FDA, GMP, ISO, and other medical device regulatory requirements.
• Proficient with applying knowledge of cleaning, disinfection, and sterilization validation principles, testing concepts, standards, and practices within a regulated environment.
• In depth technical expertise with multiple sterilization modalities (e.g, irradiation, ethylene oxide, vaporized hydrogen peroxide, moist heat).
• Proficient with applying knowledge of biocompatibility requirements, test methods, and practices within a regulated environment.
• Proficient with applying knowledge of environmentally controlled area qualification principles and monitoring requirements, standards, and practices within a regulated environment.
• Ability to communicate complex plans and technical information to team members.
• Strong technical ability to read, interpret, and contribute to development of standards and regulations.
• Strong technical ability to analyze and interpret laboratory and validation test results and to resolve test failures.
• Working knowledge of business applications such as Microsoft Office.

What happens next
Once you apply, you'll proceed to the 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.
 

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® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

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.

 Apply on company website