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8 days old

Senior Validation Engineer

Kelly Services
Cleveland, MS 38733
**Job Details:**



**Industry:** Healthcare / Pharmaceutical



**Work Location:** Cleveland, MS



**Job Title:** **Senior Validation Engineer**



**Duration:** 8 Months (Temporary/Contract)




**Senior Validation Engineer Cleveland, MS**



Plan, schedule, execute and lead Material Qualification project assignments including evaluation, selection, validation and implementation of new materials. Applies Quality Engineering principles to resolve problems in a cross functional team environment.



**Essential Duties & Responsibilities**




+ With minimal guidance, schedules and leads a team through the planning and execution of a smaller project or defined piece of a larger project. Coordinates and interfaces with Manufacturing, Logistics, Quality Control and Supplier Quality groups to assure successful project execution.

+ Makes recommendations and provides solutions using Quality Engineering principles.

+ Ability to prioritize multiple tasks.

+ Employ appropriate techniques and methods to successfully and independently execute materials qualification projects. Material qualification projects include raw materials, filters and components.

+ Identify opportunities for improving existing raw material quality and the impact on the manufacturing processes by using tools such as FMEA, SPC, Design of Experiments etc.

+ Make technical recommendations regarding materials qualification projects. Provide analysis/redesign of qualification procedures and independently select techniques to solve problems.

+ Ability to present a course of action to management and the project team with minimal assistance using both written and verbal methods.

+ Contribute to investigate sources of raw materials, coordinate technical analyses and specifications, determine impact to manufacturing processes.

+ Recommend and develop studies to determine critical raw material parameters and quality attributes. Ensures alignment between and the suppliers testing programs.

+ Apply statistical tools and risk assessment to analyze and determine solutions to problems reflecting an understanding quality and business requirements.

+ Participate in supplier audits and be able to assess suppliers quality and testing programs. Supports Supplier Quality in providing a technical evaluation of supplier notifications of changes and the impact to current processes.

+ Work with suppliers to apply process capability studies to understand and evaluate the material manufacturing process.

+ Contributes to regulatory submissions documents.

+ Present as a subject matter expert during regulatory inspections to demonstrate compliance of the qualification and quality programs.



**Qualifications**




+ Current understanding of pharmaceutical industry regulations and trends in the regulatory environment.

+ Strong interpersonal communications skills with excellent technical writing abilities.

+ Demonstrated application of engineering principles on projects.

+ Possess knowledge of GMP and regulations related to Material Qualification.

+ Proficient in Microsoft Office tools (Power point, MS Project, Excel, Word)

+ Must have the following personal attributes: integrity and trust, work ethic, sound judgment, intellectual honesty, pragmatism, courage and conviction.

+ Must have passion to innovate and drive for solutions.

+ Must display personal accountability for results and integrity.

+ Must display eagerness to learn and continuously improve.

+ Must have uncompromising dedication to quality.

+ Must have relentless focus on rapid and disciplined action.

+ Must have respect for individuals and the diverse contributions of all.



**Education and/or Experience**




+ Bachelor's degree in engineering or scientific discipline.

+ Quality Engineer Certification (QE) preferred

+ Minimum of 3-5 years of experience in technical Quality, Validation or related field in Pharmaceutical, Biotechnology or Medical Device manufacturing.

+ Validation experience related to materials used in manufacturing processes.



**Working Environment**




+ Must be able to work in controlled or clean room environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body. No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in these work environments.

+ May be around moving equipment, laboratory instruments and chemical reagents.

+ Must be able to work more than 8 hours a day or 40 hours a workweek as required.

+ Inside working conditions.

+ May be required to travel for business reasons, e.g. training and meetings.

+ Will have interaction with other people.

+ Pace may be fast and job completion demands may be high. Physical Demand The overall physical exertion of this position is sedentary work to light work.

+ May be required to use hand / finger feel for computer use.

+ May be required to move or lift testing equipment up to 20 pounds.

+ May be required to balance occasionally when completing the following job duty (Gowning).



**Why Kelly?**




+ As a Kelly Services employee, you will have access to numerous perks, including:

+ Exposure to a variety of career opportunities as a result of our expansive network of client companies

+ A competitive hourly pay rate with weekly checks

+ Access to newly expanded Medical Plan options

+ Online continuing education via the Kelly Learning Center

+ Several employee discounts

+ And more!



**Apply Today!**



**Important information:** This position is recruited by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.





**Why Kelly** **** **?**



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**About Kelly** ****



At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

\#KellyGTS
Posted: 2020-10-16 Expires: 2020-11-16

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Senior Validation Engineer

Kelly Services
Cleveland, MS 38733

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