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Senior Process Engineer

Company: Catalent
Location: Madison
Posted on: June 15, 2019

Job Description:

Senior Process Engineer 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 Process EngineerPosition Summary Catalent is looking to recruit a Senior Process Engineer to join a growing team in Madison, WI.The Senior Process Engineer will lead the tech transfer, scale up and process documentation required to transfer Phase I-III/Commercial processes from Process Development into Manufacturing. The Senior Process Engineer will be the subject matter expert for the production process activities including scale-up and technical process knowledge for specific programs. They will also manage specific client requests, attend client meetings and understands uniqueness of each process. The Senior Process Engineer will support the Program Managers and Commercial Readiness Team and drive the closure of process gaps. This position will also play a significant role in the technical support of the construction of an additional GMP operations suite. In concert with Catalent's Patient First philosophy, this role is critical to the safe and on-time delivery of our clients' products to patients by providing guidance and oversight of well-defined and documented manufacturing processes.The Role Recommends process scale-up of biological processes, leads gap analyses to identify key process parameters and equipment needs to facilitate process transfer into manufacturing.Directs the development of a strong and robust Technology Transfer process (both internal and external) to support both clinical and late phase production .Manages the authoring of Process Descriptions and Batch Records, support equipment, commissioning, process training, and validation activities.Leads facility fit activities for existing and future internally and externally transferred processes.Leads the process development component of the Commercial Readiness Team to ensure the facility and its processes are ready for Phase III / Commercial production. Champions best practices and drives adoption into the manufacturing group to improve clinical and commercial production processes The Candidate Ph.D. in Biotechnology, or related field with at least 5 years of biopharmaceutical process development and manufacturing experienceMS in Biotechnology, or related field with at least 8 years of biopharmaceutical process development and manufacturing experienceB.S/B.A. in Biotechnology, or related field with at least 10 years of biopharmaceutical process development and manufacturing experienceAssociates Degree/Certificate/Diploma in laboratory science with minimum of 15 years of biopharmaceutical process development and manufacturing experienceCatalent's standard leadership competencies that are used to interview and for Performance & Development:Leads with Integrity and RespectDelivers ResultsDemonstrates Business AcumenFosters Collaboration and TeamworkChampions ChangeEngages and InspiresCoaches and DevelopsPosition BenefitsPotential for career growth within an expanding teamDefined career path and annual performance review & feedback processCross functional exposure to other areas of CatalentMedical, Dental, Vision, and 401K are all offered from day one of employment19 days of paid time off annually + 7 paid holidays 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. More products. Better treatments. Reliably supplied. 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.

Keywords: Catalent, Madison , Senior Process Engineer, Engineering , Madison, Wisconsin

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