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Catalent Pharma Solutions Validation Engineer - Computer Systems 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 (http://www.catalent.com/index.php/about-us/Catalent-Careers2)

Our Validation Engineers are tasked with establishing validation policies/strategies to manage projects for biopharmaceutical manufacturing equipment, critical computer systems, manufacturing process, and laboratory instruments ensuring the deliverables meet the quality standards and requirements of Catalent’s policies and FDA regulations.

There is a significant opportunity to learn, develop, grow, trying new things and personally impact the business, our clients and ultimately the patients receiving the lifesaving products we manufacture. This role will help support the development and execution of validation project plans, user requirements, test strategies, electronic record and signature assessments, test protocols, and summary reports to address the Validation lifecycle (including developing GxP computer system validation and CFR 21 Part 11 related documentation).

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. This role will have the opportunity to support various clients in both large and small scale projects to specify, install/integrate, qualify, and troubleshoot systems including equipment, analytical instruments, computer systems, and automated process controls. Projects may include capital expansion projects with new state of the art filling lines.

The Role

  • You will support computer software assurance across the entire facility (including DeltaV, SCADA, and BMS automation systems).

  • You will support a computer system validation impact assessment for every new system purchased by the site for (Drug Substance, Drug Product Primary, Inspection, Packaging, and SSFFF).

  • You will provide coordination between all projects including QC analytical instruments.

  • You will assist in the oversight of qualification activities for all capital expansion projects.

  • You will provide documentation and technical support to team members and clients in Quality Assurance, Quality Control, IT, Engineering, Manufacturing Operations, Investigations, and contractors supporting various site projects.

  • You will provide assistance with keeping finished products, equipment, processes, and facilities in compliance with contemporary industry standards and regulatory filings.

  • You will assist with audits for validation/qualification documentation.

    The Candidate

  • Bachelor’s degree or higher in STEM discipline

  • Master’s degree or higher preferred

  • 2-5 years of experience in Validation or related discipline

  • 1 year GMP experience required or other regulated industry

  • Regularly applies theories and principles for one's technical discipline

  • Works independently to solve problems of moderate scope

  • Actively participates and suggests solutions to problems

    Catalent’s standard leadership competencies that are used to interview and for Performance & Development

  • Delivers Results

  • Leads with Integrity and Respect

  • Demonstrates Business Acumen

  • Fosters Collaboration and Teamwork

  • Champions Change

  • Engages and Inspires

  • Coaches and Develops

    Position Benefits

  • Defined career path and annual performance review & feedback process

  • Potential for career growth and development

  • Cross functional exposure to other areas of Quality and Production

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

  • 19 days of paid time off annually + paid holidays

  • Onsite Company gym and cafeteria

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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

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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