Sterile Parenteral Process Expert

5 days ago


Kingston, Ontario, Canada Alcami Full time

Alcami is a leading contract development and manufacturing organization (CDMO) dedicated to helping pharmaceutical and biotechnology companies bring innovative therapies to market. We are seeking a highly skilled Senior Process Engineer to join our team at our RTP facility.

About the Position

The Senior Process Engineer will be responsible for:

  • Providing technical assistance for process tech transfer and validation efforts for assigned manufacturing projects
  • Writing Master Batch Records with a strong understanding of equipment, critical process parameters, in-process tests, etc.
  • Monitoring manufacturing processes during production runs to assess any technical process issues and providing troubleshooting support as needed

You will work closely with our team to ensure timely completion and compliance with cGMP and all other relevant company training requirements.

Responsibilities

  • Performing tech transfers of new processes and technologies into the site
  • Preparing documentation to support process validation and batch manufacturing
  • Troubleshooting manufacturing processes
  • Completing process deviations and investigations
  • Coordinating lab studies with the formulation development lab

These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing Practices.

Qualifications

  • Bachelor's degree in Engineering, Pharmacy, or Chemistry
  • 5 years of experience of technical support in a sterile pharmaceutical manufacturing environment
  • Previous experience supporting tech transfer of parenteral Drug Products preferred


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