Senior Technical Process Specialist

2 days ago

Dublin, Dublin City, Ireland beBeeProcess Full time €86,333 - €104,460
Job Title: Senior Technical Process Specialist

The Senior Technical Process Specialist plays a key role in ensuring compliance, safety and reliable supply to our customers. This hybrid role involves leading technical investigations, supporting project development, and implementing process improvements.

Key Responsibilities
  • Drive compliance of global policies and execute current Good Manufacturing Practices (cGMP) in day-to-day activities.
  • Design, author, review, approve and execute qualification documentation.
  • Lead experimental design, execution, data analysis and interpretation.
  • Interpret trends in commercial process monitoring and drive further technical investigations and process changes.
  • Support the execution of development batches and change control management.
  • Lead multidisciplinary teams for process improvement and troubleshooting.
  • Facilitate investigations and participate in audits and inspections.
Requirements
  • 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 and collaboration to promote knowledge sharing.
  • Strong interpersonal skills including flexibility, collaboration and inclusion skills.
  • Technical knowledge of upstream/downstream processing and process control strategies.
  • Knowledge of regulatory/code requirements and operational intelligence & data systems.
  • Ability to articulate understanding of biologics processes and drive decision making.
Education/Experience
  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.
  • Experience leading technical related projects and preparing for regulatory audits as SME.
  • Technical operations experience in drug substance manufacture of biological molecules at commercial-scale.
  • Prior experience in drug substance process development, process characterisation studies and validation.

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