Process Engineer

at Catalent
Location Madison, WI
Date Posted July 3, 2019
Category BioPharma
Job Type Full-time
Address 726 Heartland Trail


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

Process Engineer

Position Summary

Catalent is looking to recruit a Process Engineer to join a growing team in Madison, WI.

The Process Engineer will help to manage the tech transfer, scale up and process documentation required to transfer Phase I-III/Commercial processes from Process Development into Manufacturing.  The Process Engineer will work to 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.  Support the Program Managers and Commercial Readiness Team and drive the closure of process gaps.

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.

***Please note that relocation assistance is available for the right candidate***

The Role

  • Recommends process scale-up of biological processes, supports 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.
  • Authors Process Descriptions and Batch Records, support equipment, commissioning, process training, and validation activities.
  • Participates in facility fit activities for existing and future internally and externally transferred processes.
  • Supports the process development component of the Commercial Readiness Team to ensure the facility and its processes are ready for Phase III / Commercial production.
  • Leads by example for 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 3 years of biopharmaceutical process development and manufacturing experience
  • MS in Biotechnology, or related field with at least 5 years of biopharmaceutical process development and manufacturing experience
  • B.S/B.A. in Biotechnology, or related field with at least 8 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 responsibilities

Catalent’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 Develops

Position 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 holidays

Click here to apply today.

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