Process Technology Transfer Specialist

24 hours ago

Sligo, Sligo, Ireland beBeeTechnology Full time €50,000 - €85,000
Process Technology Transfer Specialist

Role Overview:

  • Plan and coordinate process technology transfer activities to ensure seamless integration of processes and technologies.
  • Focus on the execution of process technology transfer for new products, filling, and inspection processes within the organization.
  • Utilize a risk-based approach to plan, prepare for, and execute process technology transfer activities.
  • Develop strategic partnerships with cross-functional teams to address process technology transfer challenges.
  • Provide hands-on support during engineering runs and introduce statistically based tracking metrics.
  • Identify, investigate, and resolve non-conformances, planned deviations, and change control requests.
  • Perform sample analysis in accordance with standard operating procedures (SOPs) as required.
  • Coordinate the use of external test laboratories when necessary.
  • Present process technology transfer issues and routine process monitoring data to cross-functional teams and facilitate development of business cases for recommended courses of action.

Requirements:

  • A minimum of a Master's degree in a technical discipline, such as biochemistry, chemistry, biotechnology, or biopharmaceuticals. A Ph.D. is highly desirable.
  • Operational experience in the biotechnology and/or pharmaceutical industry, with expertise in new product introductions and product support.
  • Familiarity with manufacturing processes and equipment for oral solid dose, parenterals, and/or biologicals.
  • Proven experience in authoring, reviewing, and executing process validation studies and reports.
  • Experience with vaccines, particularly in product development and stewardship, is highly preferable.
  • Cleaning validation experience is also desirable.

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