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Process Engineer

Company: Catalent Pharma
Location: Madison
Posted on: September 15, 2018

Job Description:

Job Description Process EngineerPosition Summary Catalent is looking to recruit a Process Engineer to join a growing team in Madison, WI.This position will be part of the Manufacturing Sciences group tasked with supporting the transfer, execution and monitoring of mammalian cell culture and purification processes in our manufacturing suites. The Process Engineer will support the site's strategic plan by working with Consultants, Manufacturing and Quality personnel to manage the deliverables required to prepare the Madison, WI site for early Phase and Phase III/Commercial manufacturing.The Process Engineer will develop the tech transfer, scale up and process documentation required to transfer Phase I-III/Commercial processes from Process Development into Manufacturing. This person will be the subject matter expert for the production process activities including scale-up and technical process knowledge for specific programs. The Process Engineer will also support specific client requests, attend client meetings and understands uniqueness of each process. 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

  • Evaluates process scale-up of biological processes, performs gap analyses to identify key process parameters and equipment needs to facilitate process transfer into manufacturing.
  • Supports the development of a strong and robust Technology Transfer process (both internal and external) to support both clinical and late phase production.
  • Supports 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.
  • Identifies best practices and drives adoption into the manufacturing group to improve clinical and commercial production processesThe Candidate
    • Ph.D. in Biotechnology, or related field with at least 3 years of biopharmaceutical process development and manufacturing experience
    • MS in Biotechnology, or related field with at least 4 years of biopharmaceutical process development and manufacturing experience
    • B.S/B.A. in Biotechnology, or related field with at least 7 years of biopharmaceutical process development and manufacturing experience
    • Associates Degree/Certificate/Diploma in laboratory science with minimum of 10 years of biopharmaceutical process development and manufacturing experience
    • 3+ years of relevant work experience in a current Good Manufacturing Practices (cGMP) environment with progressive responsibilitiesCatalent's standard leadership competencies that are used to interview and for Performance & Development:
      • Leads with Integrity and Respect
      • Delivers Results
      • Demonstrates Business Acumen
      • Fosters Collaboration and Teamwork
      • Champions Change
      • Engages and Inspires
      • Coaches and DevelopsPosition Benefits
        • Potential for career growth within an expanding team
        • Defined career path and annual performance review & feedback process
        • Cross functional exposure to other areas of Catalent
        • Medical, Dental, Vision, and 401K are all offered from day one of employment
        • 19 days of paid time off annually + 7 paid holidaysAbout Catalent 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.Catalent 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 along with the job number and title to . This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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 Pharma, Madison , Process Engineer, Engineering , Madison, Wisconsin

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