Process Development Engineer in Morrisville, NC

$80K - $100K(Ladders Estimates)

Catalent Pharma Solutions Inc   •  

Morrisville, NC 27560

Industry: Pharmaceuticals & Biotech


5 - 7 years

Posted 38 days ago

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

This position reports directly to the Director, Inhalation

The Research Triangle Park (RTP) facility is Catalent's Center of Excellence for Analytical Services and is also home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.

The Role

  • Responsible for technical support, product development and process validation related to new products and processes associated with Metered Dose Inhalers (Dispensing, Formulation, Filling, and Post Equilibration Testing), Nasal Sprays (Compounding, Filling and Inspection) and Dry Powder Inhalation Manufacturing (Blending, Capsule and Reservoir Filling of Devices).
  • Interacts with production personnel, equipment engineering and QC Lab as well as provides some assistance and direction for less experienced engineering and technical personnel
  • Process development lead for one or more manufacturing technologies and one or more projects
  • Execute assigned projects for the implementation of new processes, problem solving for existing processes, process optimization and process validation activities
  • Generate related documents including SOPs, Batch Documentation, Validation Plans, Protocols and Evaluations
  • Develop and execute design of experiments (DoE) to support the development and registration of manufacturing processes used to produce clinical and commercial products
  • Provide technical and operational support to meet customer commitments (internal and external)
  • Support technology transfer from client or product development into the facility and, when applicable, to commercial manufacturing

The Candidate

  • A minimum of a Bachelor's degree in engineering, life sciences, or pharmacy with 5+ years relevant experience
  • Prior experience with Nasal products, MDI and Sterile/Non-Sterile Processes or DPI manufacturing processes is ideal
  • Experience conducting DOE's for process development and process improvement desired
  • Ability to analyze data in support of technical and regulatory documents
  • Must have previous/current experience in a cGMP environment
  • Familiar with the activity sequence for process investigations and/or Root Cause Analysis
  • Familiar with Microsoft Project, Word and Excel

Position Benefits

  • Medical, Dental, Vision and 401K are all offered from day one of employment
  • 19 days of paid time off annually + 7 paid holidays

Leadership Competencies for Performance and Development

  • Leads with Integrity and Respect
  • Delivers Results
  • Demonstrates Business Acumen
  • Fosters Collaboration and Teamwork
  • Champions Change
  • Engages and Inspires
  • Coaches and Develops

Valid Through: 2019-11-7