External Manufacturing Engineer

2 weeks ago

Cork, Cork, Ireland beBee Careers Full time
Job Overview:

The External Manufacturing (ExM) Technical Operation organization is seeking a highly motivated individual for a Technical Transfer position. ExM Tech Ops is accountable for technology transfers and commercial production of Biological Drug Substance at our External Partners (EPs). This person will have the opportunity to participate in all these areas, which may include supporting the execution of technology transfers, providing manufacturing process support to resolve commercial production issues, and providing support for process and capacity optimization.

Job Requirements:

Essential responsibilities include:

  • Work with External Partners to achieve business goals and to establish a common culture that benefits our company, External Partners, and patients.
  • Responsible for technical activities for the commercial manufacturing process at the External Partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
  • Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
  • Provide on-site coverage at External Partner in support of Commercial and/or Technology Transfer Person-In-Plant Activities.
Education and Experience:

A suitable candidate should have:

  • Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
  • Minimum of 4 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance.
Communication and Teamwork:

Strong communication and teamwork skills are required for this role.

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