Manufacturing Excellence Lead

4 days ago

Dublin, Dublin City, Ireland beBeeEngineering Full time €90,000 - €120,000

Job Title:

  • Process Optimization Specialist

Job Description:

  • The Process Optimization Specialist delivers technical support to the Drug Substance Business, leading investigations and supporting significant projects across the site.
  • This role is responsible for driving compliance of Global Policies, Procedures and Guidelines, regulatory requirements and executing current Good Manufacturing Practices (cGMP) in day-to-day activities.

Key Responsibilities:

  • Design and execute qualification documentation in line with standard process.
  • Lead experimental design of studies, execution, data analysis and interpretation.
  • Interpret trends observed in commercial process monitoring and drive improvements to yield and/or robustness.
  • Support development and PPQ batches, change control management and implementation.
  • Lead multidisciplinary teams for process improvement and troubleshooting using Lean Six Sigma methodologies.
  • Participate in audits and inspections, and lead various site initiatives to improve compliance status and operational efficiency.

Requirements:

  • Strong analytical and problem-solving skills.
  • Excellent communication and team leadership skills.
  • Knowledge of process monitoring systems, automation systems and operational intelligence & data systems within a GMP manufacturing environment.

Essential Qualifications:

  • Bachelor degree in a scientific or engineering field.
  • Minimum 5 years of relevant post-degree work experience in GMP Manufacturing.
  • Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation.

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