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Catalent Pharma Solutions Validation Specialist in Kansas City, Missouri

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 (http://www.catalent.com/index.php/about-us/Catalent-Careers2)

Position Summary

The Validation Specialist will lead, manage and implement Computer System Validation (CSV) projects and support tasks, in accordance of GMP regulated activities in line with Catalent guidelines and Regulatory requirements.

In addition, the Validation Specialist will provide technical guidance as a CSV SME with respect to applicable Quality Management System (QMS) requirements, with strong emphasis on Data Integrity (DI).

The Role

  • Work closely with Validation Manager to deliver CSV projects and support tasks involving procurement, integration and implementation of new and upgrades of laboratory, instruments and applications.

  • Ensure compliance and quality in implementing and maintaining DI program deliverables.

  • Author, review and execute/approve (where applicable) CSV and Validation related documents and provide input and guidance as the KCM CSV and DI SME.

  • Ensure all CSV deliverables driven by System, Software, User Functionality and Safety Requirements are developed, executed and documented per KCM site SOPs, Global Corporate Policies and Regulatory agencies guidelines.

  • Liaison for Global CSV, IT, Business, Operations, Quality, Clients and vendors for various laboratory software, instruments, applications and technology systems.

  • Contribute to the development and revision of current validation concepts, techniques, and standards to ensure compliance to Regulatory requirements.

  • Assist in development, training and implementation of CSV policies and procedures.

  • Participate, support and drive Continuous Improvement (CI) initiatives.

The Candidate

Education or Equivalent:

Bachelor's Degree in Life Sciences, Engineering or an equivalent combination of education, training and professional expertise.

Experience:

  • 2-6 years of CSV, DI, information systems, Validation Engineering, Quality Assurance and/or Regulatory Compliance

  • 2+ years in implementation and maintenance of DI program and concepts

  • 2+ years in the Life Sciences industry or laboratory experience.

Knowledge/Skills Requirements:

  • Strong and in-depth knowledge of CSV, DI and Validation.

  • Solid application towards regulatory compliance, vendor/client/regulatory audits, SxP development, Change Management, CAPA and various Quality Systems Regulation disciplines.

  • Familiarity with cGMPs, ISPE GAMP5, fundamental validation practices and the following FDA and European Commission Regulations:

  • 21CFR210 - Current Good Manufacturing Practice in Manufacturing.

  • 21CFR 211, Current Good Manufacturing Practice for Finished Pharmaceuticals.

  • 21CFR820, Quality System Regulation

  • 21CFR11 - Electronic Records, Electronic Signatures.

  • EudraLex, Volume 4, Good Manufacturing Practices, Annex 11 Computerized Systems

Catalent’s leadership competencies

  • Leads with Integrity and Respect

  • Delivers Results

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

Position Benefits:

  • Medical, Dental, Vision and 401K are all offered from day one of employment

  • 19 days of paid time off annually

  • Potential for career growth within an expanding team

  • Defined career path and annual performance review and feedback process

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 www.catalent.com/careers 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 DisabilityAccommodations@catalent.com . 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 (https://catalent.wd1.myworkdayjobs.com/External) 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 (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .

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