Engineering Lead

6 days ago


Dublin, Dublin City, Ireland beBeeProcess Full time €96,000 - €108,000
Senior Process Engineer Job

We are recruiting a Senior Process Engineer to join our team.

Job Purpose:

The MS&T Process Engineer provides technical support to the Drug Substance Business, leading technical investigations and supporting major site projects.

Key Responsibilities:
  • Ensure compliance with Global Policies, Procedures and Guidelines in daily activities.
  • Design, author, review, approve and execute qualification documentation in line with standard processes.
  • Lead experimental design of studies, execution, data analysis and interpretation.
  • Interpret trends in commercial process monitoring and support further technical investigations and process changes.
  • Support the execution of development and PPQ batches, change control management and implementation.
  • Lead multidisciplinary teams for process improvement and troubleshooting using Lean Six Sigma methodologies.
  • Lead and facilitate investigations with effective Root Cause Analysis and CAPAs.
Requirements:
  • Demonstrated leadership and change management with a continuous improvement mindset.
  • A proven track record of developing and coaching teams to high performance.
  • Experience leading technically focused projects and presenting in front of regulatory audits as an SME.
  • Techncial qualifications in Applied Pharmaceutical/Biological/Chemical sciences or related engineering field.
Technical Expertise:
  • Subject Matter Expert in upstream/downstream processing and process control.
  • Knowledge of analytics, automation systems, and operational intelligence & data systems within a GMP environment.
  • Strong technical writing skills to articulate an understanding of biologics processes to drive decision-making.
Seniority Level:
  • Mid-Senior level

This is an initial 11-month contract with potential extension.



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