Senior Process Development Engineer

22 hours ago

Dublin, Dublin City, Ireland beBeeProcess Full time €100,000 - €150,000

Job Title: Senior Process Engineer - MS&T

About the Role:

We are seeking a highly skilled and experienced Senior Process Engineer to join our team. As a Senior Process Engineer, you will be responsible for leading process development and implementation, ensuring that our processes meet the highest standards of quality and safety.

Responsibilities:

  • Lead process development and implementation, including design, authoring, reviewing, approving, and executing qualification documentation.
  • Develop and execute experimental designs, lead data analysis and interpretation, and interpret trends observed in commercial process monitoring.
  • Support the execution of development and production batches, change control management, and implementation.
  • Lead multidisciplinary teams for process improvement and troubleshooting with end-to-end product focus through Lean Six Sigma methodologies.
  • Investigate issues, conduct root cause analysis, and implement corrective actions.
  • Participate in audits and inspections, and support site initiatives to improve compliance status and operational efficiency.
Requirements:

To be successful in this role, you will need:

  • Subject Matter Expertise in upstream/downstream processing and process control strategies, with working knowledge of analytics.
  • Knowledge of process monitoring systems, automation systems (DeltaV), and data systems (Pi System) within a GMP environment.
  • Knowledge of regulatory requirements to Irish, European, and international standards.
  • Evidence of continuous professional development, technical writing skills, and ability to articulate understanding of biologics processes.
Education and Experience:

You will have:

  • Relevant technical qualifications in Applied Pharmaceutical / Biological / Chemical sciences or applied technical / engineering.
  • Experience in upstream cell culture and/or downstream purification of biological molecules.
  • Experience presenting in front of regulatory audits as Subject Matter Expert.
  • Technical operations experience in drug substance manufacture of biologics at commercial scale.
Seniority Level:

This is a contract position.

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