Catalent Pharma Solutions Senior Process Validation Engineer in Bloomington, Indiana
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)
Senior Process Validation Engineer
A Validation Engineer will participate in validation projects relating to Process Performance Qualification (PPQs), control strategy development, mixing and hold studies, manufacturing processes and new component and equipment qualification.
The Process Validation Engineer will support the Process Validation Team in all areas of the facility (Drug Substance, Drug Product Formulation/Fill/Finish and Inspection/Packaging).
Catalent’s Bloomington location provides drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients live better, healthier lives.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employees.
Coordinate multiple projects, documenting activities and summary report templates
Interact in a client facing position to support customer product launches
Establish new templates, validation documentation and procedures
Review process changes and provide input on re-validation
Assessing risks involved in processing steps and related to equipment, developing and/or reviewing validation requirements and design deliverables
Partner with contract validation teams to support and monitor efforts
Monitoring validation strategies, ensure polices are followed, conducting validation studies in accordance with batch records/protocols
Identify exceptions associated with validation protocol execution
Bachelor’s degree (required) in STEM discipline
Master’s degree or higher preferred
5-8 years of experience in Validation or related discipline
2 year GMP experience required or other regulated industry
Competent at-risk mitigation for function
Previous direct contact with clients and internal customers (Customer Facing experience) preferred
Excellent communication skills
Self-motivated and action oriented
Catalent’s standard leadership competencies that are used to interview and for Performance & Development
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
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) .
Catalent Pharma Solutions
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