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Process Engineer III - Manufacturing

Posted by: Pearl Therapeutics

Posted date: Jul-15-2015

Location: Research Triangle Park

Description of Duties

  • Plan and lead process scale-up studies
  • Support technology transfer of processes to external sites (CMO and AZ sites)
  • Work with the New Product Introduction team at the AstraZeneca manufacturing site
  • Support packaging process development for Pearl products
  • Implement Process Analytical Technologies and In-Process Controls as needed to attain high standards of process control
  • Coordinate samples transit and testing in support of studies
  • Summarize data and author technical reports
  • Contribute to relevant sections of Regulatory submissions, and preparations for PAI
  • Support product validation and launch manufacture

 

Minimum Requirements

  • A BS degree (or higher) in Pharmaceutical Sciences, Chemical/Mechanical engineering, or similar discipline. 5+ years of pharmaceutical manufacturing experience
  • Working knowledge of pharmaceutical manufacturing processes and systems, specifically MDI manufacturing and packaging equipment
  • Knowledge of relevant ICH, USP, EP, and FDA guidance documents as well as cGXP’s

 

 

Behaviors/Skills:

  • Demonstrated experience with successful collaboration and influencing
  • Proficiency in Microsoft office suite of programs (Word, Excel, PowerPoint, Visio, & Outlook)
  • Strong written, oral, & presentation communication abilities
Job Title Process Engineer III - Manufacturing
Post Details
Email shannon.slattery(at)taylor-strategy.com
Employer's Website http://
Category
Job Discipline Job Discipline -> Biotech
Job Classification Job Classification -> Engineering
Job Type Job Type -> Full-time
Location Research Triangle Park
Key Words Protocols, Validation, Manufacturing, Transfer
Start Date --
Deadline