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Engineering Compliance Associate

Company: BAXTER
Location: Bloomington
Posted on: August 7, 2022

Job Description:

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission. Position SummaryThe Engineering Compliance Specialist is a hands-on role responsible for overseeing and managing the investigation and on time closure of equipment deviations, equipment records review process, and compiling performance metrics within the equipment, facilities and validation functions. This role also ensure the department s compliance with and conformance to Environmental Health and Safety (EHS) and Baxter s Global Engineering Standards (GES).Duties and Responsibilities

  • Manage the timely review and investigation of engineering and maintenance-related deviations and respond to equipment record queries from internal / external sources
  • Oversee timely completion of any required Engineering-related corrections within quality events in accordance with the procedural requirements
  • Ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause
  • Assist with implementation and supporting on-going continuous improvements
  • Follow up with Deviation/CAPA owners to make sure all new Deviations/CAPA's are completed on time in accordance with batch release schedule
  • Prepare and publish weekly departmental metrics
  • Interface with Quality, Supply Chain, Manufacturing, Project Management and Maintenance personnel to accomplish department performance objectives
  • Participate or provide ownership of CAPA related to engineering or equipment
  • Contribute to development and validation of process improvements, SOPs, and staff training
  • Assist in compiling information for the Key Performance Indicators (KPI) on an as needed basis
  • Attend and complete all mandatory training
  • Oversee and participate in the recruitment and selection and successful onboarding of department staff
  • Other duties as assignedRegulatory Responsibilities
    • Support Quality Assurance investigation function during FDA, corporate GMPs, EHS and GES, as well as customers compliance audits
    • Participate in internal audits as applicableSupervisory Responsibilities
      • Provide leadership in daily operations and have employees incorporate these compliance practices into their daily routinesEducation and Experience Requirements
        • Bachelor s degree in a related field
        • One (1) year of relevant post-degree work experience in a laboratory, cGMP, quality, EHS or other position
        • An equivalent combination of education and experience may be consideredKnowledge, Skills & Abilities
          • Proficient in the use of MS office applications such as Word, Excel, PowerPoint and Adobe Acrobat
          • Basic understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
          • Familiarity of engineering concepts
          • Time management
          • Attention to detail while executing multiple tasks
          • Well-organized
          • Good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skillsPhysical Requirements
            • Frequent standing and walking throughout the facility
            • Satisfactory audio-visual acuity The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law. Equal Employment OpportunityBaxter 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 globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice . 069810

Keywords: BAXTER, Bloomington , Engineering Compliance Associate, Engineering , Bloomington, Indiana

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