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Principle Quality Engineer - Deviation Writer

Company: Catalent
Location: Bloomington
Posted on: September 23, 2019

Job Description:

Job DescriptionPosition Overview:-- Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent---s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love.-- Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start herePrinciple Quality Engineer --- Deviation WriterPosition SummaryCatalent is seeking a Quality Engineer --- Deviation Writer to join our growing Engineering team in Bloomington, Indiana.Our Principle Quality Engineer (QE) --- Deviation Writer---s primary duty is to ensure each deviation is thoroughly investigated and Quality impact assessed. A QE deviation writer must ensure timely completion of deviations within the Trackwise system to support our quality metrics, on time batch release and patient first. They will make recommendations for improvement or correction based on the Root Cause Analysis of the deviations. The quality engineering deviation team supports the manufacture of pharmaceutical products and often requires direct contact with clients and internal customers across the site. This is done through ensuring that documentation is accurate and effectively assessing and mitigating risk associated with manufacturing activities. Successful candidates will have excellent communication skills, be self-motivated and action oriented. This department requires individuals to independently problem solve, work cross functionally, suggest Corrective and Preventative Actions (CAPAs), take ownership for their deviations and drive to meet deadlines.In concert with Catalent---s Patient First philosophy, your role is paramount to ensure the efficacy and quality of our manufacturing processes which will ultimately yield safe drug products for patients.Principle Quality Engineer In This Role--- You will perform Root Cause Analysis and Investigations in Trackwise--- You will be clearly articulating issues identified during the investigations and utilizing your strong technical writing skills to document them--- You will actively participate in cross functional discussions and suggest solutions to problems--- Considered a subject matter expert and the go to person for complex, difficult to solve problems--- Skilled at risk mitigation and prediction--- Routinely suggests new, innovative solutions to routine and complex problemsTYPICAL MINIMUM EDUCATION AND/OR EXPERIENCE: --- Bachelor---s degree, STEM discipline preferred--- PhD or Certification (i.e. PE) preferred--- 8+ years of experience--- 3 years GMP experience requiredCatalent offers rewarding opportunities to further your career!-- Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.-- ---- --personal initiative. dynamic pace. meaningful work.Visit to explore career opportunities.---- --Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.------ --Notice to Agency and Search Firm Representatives:--Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting.-- Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent.-- No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.-- Thank you.

Keywords: Catalent, Noblesville , Principle Quality Engineer - Deviation Writer, Engineering , Bloomington, Indiana

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