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Sterility Assurance Validation Associate I

Company: Baxter
Location: Bloomington
Posted on: May 16, 2019

Job Description:

*About Baxter * Every day, millions of patients and caregivers rely on Baxter's leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we've been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter's employees worldwide are now building upon the company's rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit ************** and follow us on Twitter, LinkedIn and Facebook. Summary The Sterility Assurance Validation Associate I is responsible for the management and the execution of project and system qualifications, and validation confirmations including equipment and processes. The Validation Associate I ensures compliance that meets worldwide regulatory agency requirements, internal company standards/best practices and current industry practices. This position reports to the Sr. Manager, Technical Services Validation. Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned): * Create protocols, new processes and reports of validation activities in its entirety that will be reviewed by regulatory auditors and clients * May participate and respond to client audits and regulator inspections * Serve as line owner, conducting gap assessments for Sterility Assurance Validation when onboarding new projects * Subject matter expert for operation and equipment specific programming of select critical equipment * Serve as department representative for client audits and may be asked to formulate responses for audit observations. * Train on NCR investigation, CAPA system, and Change Control Management system. Will be assigned CAPAs and Change Control Management action items * Participate in semi-annual HEPA filter certification testing (integrity testing, velocity testing, visible smoke testing) * Maintain and generate accurate and complete records, reports and documentation as required for summary preparation. * Serves as the lead team member for validating new projects on known technologies and equipment. * Conduct development studies on critical equipment * Serve as department representative for media fill simulations. Education and Experience: * Bachelors degree required, preferably in science or technical area * Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, Ellab Valsuite Pro, Kaye software, etc.) * Critical thinking and problem solving skills a must * High initiative and ability to deal with ambiguity a must Physical / Safety Requirements: * Ability to meet Grade A and B gowning requirements. * Ability to lift 50 lbs. * Must be able to climb and work from ladders. * Must be able to qualify for 20/25 corrected vision. * Duties will require some overtime work, including nights and weekends * Use of hands and fingers to manipulate office equipment is required * Position requires standing for long hours, but may involve walking or sitting for periods of time. A Career That Matters Baxter's employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day. Equal Employment Opportunity 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. EEO is the Law EEO is the law - Poster Supplement Pay Transparency Policy Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to *********************** and let us know the nature of your request along with your contact information. Job: *Technical Services Organization: *Global Operations - Manufacturing Title: Sterility Assurance Validation Associate I Location: Indiana-Bloomington Requisition ID: ******Q6

Keywords: Baxter, Bloomington , Sterility Assurance Validation Associate I, Other , Bloomington, Indiana

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