Process Engineer - Equipment

Catalent Pharma Solutions Inc   •  

Madison, WI

Industry: Pharmaceuticals & Biotech

  •  

11 - 15 years

Posted 77 days ago

This job is no longer available.

Position Summary

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

The Process Engineer - Equipment 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. This position 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 Phase III/Commercial manufacturing.

The Process Engineer - Equipment will support the facility and its teams to drive the closure of process and equipment gaps. This position will evaluate and develop the documentation necessary to specify, purchase, install and commission new equipment and custom disposable consumables, as well as evaluate existing equipment for uniformity between Process Development and Manufacturing. The Process Engineer - Equipment position will also play a significant role in the technical support of the construction of any new GMP operation areas and will transition into a key role in the Technical Operations Group supporting the transition from Development to Manufacturing. 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.

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

  • Works with stakeholders on leading implementation plans and experimentation between development and manufacturing, including development of quality and business attributes for equipment
  • Develops required documents for the design and purchase of new equipment and custom disposables
  • Oversees the purchasing process including, but not limited to: selecting vendors, site visits as required, Factory Acceptance Testing, Site Acceptance Testing, Installation oversight, Commissioning and qualificationsupport.
  • Serves as an equipment SME to understand the state of existing equipment and gaps
  • Provides support or leads investigations due to potential equipment failures
  • Establishes and maintains working understanding of Process Development and Manufacturing Equipment

The Candidate

  • Ph.D. in Chemical or Mechanical Engineering, Biotechnology, or related field with at least 3 years of biopharmaceutical process development and manufacturing experience
  • MS in Chemical or Mechanical Engineering, Biotechnology, or related field with at least 4 years of biopharmaceutical process development and manufacturing experience
  • B.S/B.A. in Chemical or Mechanical Engineering, 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

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
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