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Validation Engineer

Req #: 170001TR_en
Location: Castlebar, C IE
Job Category: Quality
Date Posted: 11/1/2017 7:41:05 AM
Baxter International

Validation Engineer

Our employees around the world are connected by an enduring commitment to save and sustain lives. This higher purpose binds us as a company in doing work that matters.



Do you want to know why it is so wonderful to work for Baxter? Go to https://www.youtube.com/watch?v=OY89yj_zSIo

 The Job 


     Process Validation against Corporate SOP/FDA/EMEA requirements   Accountable for writing,   executing & reporting validation documentation (DQ / FAT / IQ / OQ / PQ / PPQ / pFMEA).

        Execution and documenting of process risk assessment / failure mode and effects analysis. 


     Statistical analysis of data to determine process capability through Cpk and other statistical techniques.


      Performing of validation functional testing as required. 


    Track and resolve exceptions during qualification activities.


   Partcipate in cross functional teams.


   Ensure all information is recorded correctly and compliant with GDP.


  Assist in execution of validation protocols.


 Development of project plans to validate processes.


Validation projects will be across a range of production areas which may include automation, filling, mixing, cleaning, software, utility and facility projects.


  Do  you want to learn more about our business? Go to http://www.baxter.com/inside-baxter/about/overview/corporate.page 



Who you are you
  ·         Bachelor of Engineering or Science Degree in Engineering or Technology related discipline.


  ·         Min 3-5 years experience in validation in an automated/pharma manufacturing environment.



·         In-depth knowledge of validation processes.



·         Knowledge of Pharma/Medical product manufacturing, especially automated processes or filling operations.



·         Project Management skills.



·         Excellent interpersonal, communication & technical report writing skills



·         Experience in process, software, filling and automation process validation.



·         Experience in mixing & cleaning validation with understanding of associated chemistry and microbiology requirements.


·         Experience with Minitab or similar stastical package.


·         Ability to understand manufacturing processes.


·         Must be flexible and able to manage multiple priorities simultaneously.





·         Experience in FDA or IMB regulated manufacturing.



        What we offer

         It is a challenging opportunity for you and also a chance to work in a diverse team with a great mix

         of  people. Joining Baxter means joining a team that you can truly learn from!


  • We encourage our employees to develop their skills to meet the demands of an ever-changing work environment, providing them with opportunities to achieve personal and professional goals that will make them valued contributors throughout their careers. If you have an interest in this great opportunity and think you can make a difference then this could well be the role for you.



    If you want to learn more about career opportunities go to http://www.baxter.com/careers.page



    Who we are



    Baxter touches millions of lives every day. Our products and services are essential building blocks of healthcare. You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide. You’ll find us in clinics and in the home. Patients and providers rely on Baxter for lifesaving renal and medical products.



    Our mission to save and sustain lives inspires our work and our commitment to expanding access to care, providing cost-effective healthcare solutions, delivering quality products and advancing innovations for the world.



    Our 50,000 employees serve patients and clinicians in more than 100 countries and are dedicated to ensuring Baxter is there when patients need care.



    Our inclusive culture and a diverse workforce drives innovation, creates trusted partnerships with customers, suppliers, and community partners, and contributes to the success and sustainability of our business.



    Every day at Baxter is a chance to save and sustain people's lives.



    Equal Opportunity Employer Discrimination: Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
















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