Process Improvement Engineer

7 days ago

Dublin, Dublin City, Ireland beBeeProcessImprovement Full time €85,938 - €104,183
Technical Process Improvement Specialist

  We are seeking a Technical Process Improvement Specialist to join our team. As a Technical Process Improvement Specialist, you will lead investigations, support projects, design equipment, and ensure compliance with regulations.

  Key Responsibilities:

  • Drive compliance of global policies, procedures, and guidelines, as well as execute current Good Manufacturing Practices (cGMP).
  • Design, author, review, approve, and execute qualification documentation.
  • Lead experimental design, execution, data analysis, and interpretation. Author and review batch documentation, regulatory, and technical documentation.
  • Interpret trends observed in commercial process monitoring, and drive improvements to yield and robustness.
  • Support development and process performance qualification batches, change control management, and implementation.
  • Lead multidisciplinary teams for process improvement and troubleshooting using Lean Six Sigma methodologies.
  • Facilitate root cause analysis and CAPAs, participate in audits and inspections.
  • Maintain focus on quality and safety compliance, and prioritize customer satisfaction.

  Qualification and Experience:

  • Demonstrated leadership and change management skills with a continuous improvement focus.
  • Proven track record of delivering high performance through team development and coaching.
  • Evidence of continuous professional development.
  • Strong collaboration to promote knowledge sharing and best practices across the site.
  • Motivation to be an inspiring member of a high-performing team, and a desire to continuously learn and improve.
  • Demonstrated interpersonal skills, including flexibility, collaboration, and inclusion.

  Technical Requirements:

  • SME in upstream/downstream processing and process control strategies.
  • Working knowledge of analytics, process monitoring systems, automation systems, operational intelligence & data systems within a GMP manufacturing environment.
  • Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
  • Ability to effectively articulate understanding biologics processes, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
  • Relevant technical qualification(s) in Applied Pharmaceutical/Biological/Chemical sciences or applied Technical/Engineering qualification.
  • Experience leading technical-related projects, technology transfer, regulatory filing, and commercial drug substance manufacturing of biologics.
  • Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections, and working with external contract organizations.

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