Process Validation Specialist

5 days ago

Sligo, Sligo, Ireland beBeeProcessScientist Full time €60,000 - €80,000
Process Scientist Job Opportunity

We are seeking a skilled process scientist to support our quality team in Ireland.

  • Promote the successful introduction of new processes and technologies by planning and coordinating technical transfer activities.
  • Develop clear instructions for production operations, including tableting and packaging procedures.
  • Analyze data from technical transfer activities and collaborate with the scheduling team to ensure timely execution.
  • Serve as a technical resource to the manufacturing team throughout the manufacturing process and develop necessary protocols.
  • Apply a risk-based approach for planning, readiness, and execution of technical transfer activities.
  • Establish effective partnerships with site business units to address technical transfer-related issues.
  • Provide on-the-floor process support and introduce statistically based tracking metrics.
  • Monitor critical process parameters (CPPs) and update process databases.
  • Investigate and resolve non-conformances, deviations, and change control requests.
  • Perform sample analysis and coordinate external test laboratories when required.
Required Skills and Qualifications
  • A Master's degree in a technical discipline such as biochemistry, chemistry, biotechnology, or biopharmaceuticals.
  • A Ph.D. is highly desirable.
  • At least 5 years of experience in the biotechnology and/or pharmaceutical industry, with operational experience in new product introductions and product support.
  • Familiarity with pharmaceutical manufacturing processes and equipment such as oral solid dose, parenterals, and biologicals.
  • Experience in authoring, reviewing, and executing process validation studies and reports.
  • Familiarity with vaccines is an asset, particularly in product development and stewardship.
  • Proficiency in written and spoken English.
  • Excellent understanding of Good Manufacturing Practices (GMP), ICH, and compendia regulations and guidance.
  • Strong problem-solving, risk management, and decision-making skills.
  • Excellent collaboration and communication skills.
  • Attention to detail and significant data review experience.
  • Effective time management and multi-tasking skills.

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