Principal Specialist, Computerized System Validation and Compliance


Boehringer Ingelheim


Posted Under: Atlanta, Georgia jobs in Other; Other jobs in zipcode 30301
Posted On: 2019-10-11 00:00:00

Description:Description\:
The individual will approve, review, author and execute programs, protocols, procedures and policies to provide company-wide support for the validation of computers and computerized system assuring GxP regulatory compliance. In addition, the individual will assume the Quality Assurance audit function for computerized systems and provide technical guidance for the implementation of computers and computerized systems for BIAH. In addition, the position may include GxP system administration and business process development reponsibilities for company-wide or global applications.?As an employee of Boehringer Ingelheim, youwill actively contribute to the discovery, development and delivery of ourproducts to our patients and customers. Our global presence providesopportunity for all employees to collaborate internationally, offeringvisibility and opportunity to directly contribute to the companies' success. Werealize that our strength and competitive advantage lie with our people. Wesupport our employees in a number of ways to foster a healthy workingenvironment, meaningful work, diversity and inclusion, mobility, networking andwork-life balance. Our competitive compensation and benefit programs reflectBoehringer Ingelheim's high regard for our employees.?Duties & Responsibilities\:
  • Independently identifies, develops and implements Computerized System Validation and Compliance (CVSC) procedures and improvements both within the department and across the organization with active collaboration with all potential stakeholders.
  • Applies in-depth knowledge and broad application of relative practices, techniques and standards to the direction, implementation and execution of the validation process.
  • Structured ability to identify, define and initiate organizational goals and priorities for multiple CSVC projects problems through the assimilation of data, establishing facts and drawing valid conclusions to deliver results that take into consideration resources, constraints and business needs.
  • Manages or leads projects; can include responsibility for project budgets and resources including managing the activities of external consultants. Applies knowledge and experience to a wide range of situations, potentially within multiple work units.
  • Demonstrates a depth and breadth of knowledge in own discipline that is applied to a wide range of situations and regulatory requirements that, also, supports the mentoring and training of colleagues to problem resolution.
  • Accountable for individual contributor excellence competencies and personal performance behaviors, action plans and feedback process; drives team and area results based on business needs.
  • As required, assumes a system administrator, program developer and/or subject matter expert role(s) for critical quality and compliance GxP end-use applications supporting Vetmedica-wide or global business processes.
  • Performs all Company business in accordance with all regulations (e.g. EMA, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management. Demonstrated high ethical and professional standards with all business contacts in order to maintain BIVI?s excellent reputation in the community.Requirements\:?
    • Bachelor?s degree with a focus in Engineering AND/OR Other Professional Training, AND/OR Master's degree (e.g. MBA, MSc) with a focus in IS/IT
    • At least 5 years of relevant and productive experience in a regulated industry such as pharmaceutical, vaccine or nuclear operations.
    • Thorough understanding of validation requirements for GxP systems as expressed by the FDA, EU or other regulatory agencies with special focus on EU Annex 11 and 21 CFR Part 11.
    • Excellence in comprehension, theoretical knowledge, practical knowledge and application of FDA, USDA and EU regulatory requirements for the production and distribution of pharmaceutical and vaccine regulated articles.
    • Strong theoretical knowledge, practical knowledge and application of computerized systems, programming, relational databases and information technology.
    • Experience or exposure to computer system administration, validation and protocol creation.
    • Familiarity with GAMP and other approaches to System Development Life Cycles (SDLC).
    • Demonstrated ability to work in a team environment.
    • Attention to detail with exceptional logical skills with excellence in writing and verbal communication.?Desired Experience, Skills and Abilities\:??
      • At least 6 years experience working in an FDA/EU regulated environment.
      • More than six (6) years leadership experience
      • Extensive experience in validation, IT/IS including programming, business process and system administration.
      • Practical experience in science, engineering, IT/IS or general operations support.Eligibility Requirements\:
        • Must be legally authorized to work in the United States without restriction.
        • Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background
        • Must be willing to take a drug test and post-offer physical (if required)
        • Must be 18 years of age or olderWho We Are\:At Boehringer Ingelheim wecreate value through innovation with one clear goal\: to improve the lives ofpatients. We develop breakthrough therapies and innovative healthcare solutionsin areas of unmet medical need for both humans and animals. As a family ownedcompany we focus on long term performance. We are powered by 50.000 employeesglobally who nurture a diverse, collaborative and inclusive culture. Learningand development for all employees is key because your growth is our growth.?Want to learn more?? Visit boehringer-ingelheim.com and join us inour effort to make more health.?Boehringer Ingelheim,including Boehringer Ingelheim Pharmaceuticals, Inc., Boehringer Ingelheim USA,Boehringer Ingelheim Animal Health USA, Inc., Boehringer Ingelheim Barceloneta,LLC and Boehringer Ingelheim Fremont, Inc. is an equal opportunity and affirmativeaction employer committed to a culturally diverse workforce.? All qualified applicants will receiveconsideration for employment without regard to race; color; creed; religion;national origin; age; ancestry; nationality; marital, domestic partnership orcivil union status; sex, gender identity or expression; affectional or sexualorientation; disability; veteran or military status, including protectedveteran status; domestic violence victim status; atypical cellular or bloodtrait; genetic information (including the refusal to submit to genetic testing)or any other characteristic protected by law..