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Catalent Pharma Solutions Senior Quality Engineer - Deviation Writer in Bloomington, Indiana

Job Description

Position 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 here (

Senior Quality Engineer - Deviation Writer

Catalent is seeking a Senior Quality Engineer to join our growing Quality Engineering team in Bloomington, Indiana.

Our Quality Engineers support the manufacture of pharmaceutical products and often require direct contact with clients and internal customers across the site. This is done through ensuring that documentation is accurate, performing studies to demonstrate measurements are reproducible and repeatable, 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, take ownership of their projects and drive to meet deadlines. Our Quality Engineer’s primary duty is to conduct root cause analysis and investigations, support batch release to patients and make recommendations for improvement (Corrective actions and Preventative Actions).

Catalent Biologics is making significant investments in people and capabilities. 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.

In This Role

  • Conduct root cause analysis, problem solving activities, Deviations, suggest CAPAs

  • Apply theories and principals for your technical discipline

  • Work independently to solve problems of moderate to large scope

  • Work with cross-functional teams including Engineering, Technical Services and Manufacturing

  • Actively participate and suggest solutions to problems

  • Support our clients and Patients with batch release

The Candidate

  • Bachelor’s degree, STEM discipline preferred

  • Master’s degree or higher - Preferred

  • 5 years or more of experience in Quality Engineering or related discipline

  • 1-year GMP experience required or other regulated industry

  • Must be able to read and understand English-written job instructions and safety requirements.

Catalent 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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.Visit to explore career opportunities.

C atalent 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.

Catalent = Catalyst + Talent

Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!

personal initiative. dynamic pace. meaningful work.

Catalent is the perfect place to grow your career if…

  • You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).

  • You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!

  • You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.

  • You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.

  • You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking ( for YOU!

  • See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here ( .