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Validation Engineer | Tampa, FL (On-Site)

Contract 1 + year

This position will perform and support the validation of manufacturing/ packaging equipment, facilities, utilities, computerized systems, temperature-controlled areas/equipment, Media Fills, and sterilization processes associated with the manufacture of pharmaceutical products to assure compliance with cGMP’s, Regulatory, and BLP’s guidelines.

Responsible for ensuring functional areas, projects, and/or systems are compliant following Computer System Validation (CSV) and Data Integrity standards and other validation/regulatory requirements. The role will provide independent compliance oversight as a validation compliance lead for the systems installed at the site. Job assignments are to be completed without a considerable amount of supervision.

Responsibilities

+ Develop sound scientific rationale/strategy for commissioning and qualification of new or modified cGMP environment, equipment and processes.

+ Design, implement and execute protocols to validate manufacturing equipment, facilities and utilities in a manufacturing environment following the latest cGMP regulations.

+ Partner with Engineering to develop/execute commissioning

+ On-site support of validation, qualification and requalification activities at the Tampa site.

+ Management of multiple projects and requalification effectively

+ Participate in continuous improvement projects related to validation programs and procedures.

+ Evaluate test data and write final reports to summarize testing performed. Gather all pertinent documentation required for completing the validation activity.

+ Able to don cleanroom garments and enter aseptic manufacturing as required for job responsibilities.

+ Suggest and Participate in CI/CIP/compliance related projects.

+ Communicate the requirements, scheduling, results and impact of the performance of the above projects to ensure efficient and successful turnover of validated equipment or systems to the customer in support of the manufacture of sterile pharmaceutical product.

+ Ability to run multiple projects and coordinate personnel.

Qualifications

+ Minimum 5 years of Engineering or Validation experience.

+ Experience in the following types of validation is desired: Utilities, facilities, manufacturing equipment (compounding, filling, and packaging), sterilization processes including moist heat, dry heat, gamma, e-beam, x-ray and ethylene oxide; Media Fills, temperature-controlled area/equipment.

+ Computerized systems/SQA experience is a plus.

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 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 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.