Project Validation Specialist - Kelly Services
Anasco, PR 00610
About the Job
Summary Description:
The position is to support the implementation of labeling / artwork changes on Duragen product family for CE and non-CE marked SKUs. The incumbent will be supporting the following activities to ensure conformance with global labeling SOP for Duragen products manufactured at Integra Añasco.
• Data Gathering – Participate in the discovery and compilation of required documentation to be updated as part of the Labeling / artworks changes implementation.
• Labeling / artworks changes implementation – Assess and update all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production router/instructions, procedures) to implement Labeling / artworks changes. Perform tasks identified as part of the implementation plan including, but not limited to generation and execution of change control, technical reports / memos, First Article Inspections, and manufacturing documentation update through site change orders system (Agile).
The incumbent will be working with cross functional areas on activities described above. Responsible for the delivery of tasks to ensure conformance to the project plan schedule.
Education and/or experience:
• BS in Science or Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical.
• Hands-on experience with EU MDR or MDD remediation projects, compliance projects and process validation required.
• Experience with managing documents within electronic PLM system.
• Experience with working with cross functional team.
• Minimum of 5 – 7 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least five (5) years in manufacturing process, quality or validation engineering position and preferably with exposure to Packaging Validations, Design Control and Product/Process Transfer.
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.
The position is to support the implementation of labeling / artwork changes on Duragen product family for CE and non-CE marked SKUs. The incumbent will be supporting the following activities to ensure conformance with global labeling SOP for Duragen products manufactured at Integra Añasco.
• Data Gathering – Participate in the discovery and compilation of required documentation to be updated as part of the Labeling / artworks changes implementation.
• Labeling / artworks changes implementation – Assess and update all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production router/instructions, procedures) to implement Labeling / artworks changes. Perform tasks identified as part of the implementation plan including, but not limited to generation and execution of change control, technical reports / memos, First Article Inspections, and manufacturing documentation update through site change orders system (Agile).
The incumbent will be working with cross functional areas on activities described above. Responsible for the delivery of tasks to ensure conformance to the project plan schedule.
Education and/or experience:
• BS in Science or Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical.
• Hands-on experience with EU MDR or MDD remediation projects, compliance projects and process validation required.
• Experience with managing documents within electronic PLM system.
• Experience with working with cross functional team.
• Minimum of 5 – 7 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least five (5) years in manufacturing process, quality or validation engineering position and preferably with exposure to Packaging Validations, Design Control and Product/Process Transfer.
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® 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.
Source : Kelly Services