Senior Process Engineer MS&T

3 weeks ago

Dublin, Dublin City, Ireland RT Full time
Overview

Process Engineering contract role requiring experience in drug substance process development and biologics. Details on compensation are provided by RT.Lane; final pay is based on skills and experience.

Responsibilities
  • Design/Author/Review/Approve/Execute qualification documentation in line with the standard process.
  • Lead experimental design of studies, execution, data analysis and interpretation.
  • Interpret trends observed in commercial process monitoring.
  • Support the execution of development and PPQ batches, change control management and implementation.
  • Lead multidisciplinary teams (manufacturing science and technology, quality, analytics, regulatory) for process improvement and troubleshooting with end-to-end product focus through Lean Six Sigma methodologies.
  • Lead and facilitate investigations, ensuring effective Root Cause Analysis and CAPAs. Participate in audits and inspections.
  • Lead and/or support site initiatives to improve compliance status and overall operational efficiency.
  • Support MS&T organizational initiatives (examples include safety, financial forecasting, work standardization, etc.).
  • Maintain continuous focus on quality and safety compliance and customer focus.
Technical Requirements
  • Subject Matter Expert in upstream/downstream processing and process control strategies; working knowledge of analytics.
  • Knowledge of process monitoring systems, automation systems (DeltaV), and data systems (Pi System) within a GMP environment.
  • Knowledge of regulatory/code requirements to Irish, European and international standards.
  • Evidence of continuous professional development; technical writing skills.
  • Ability to articulate understanding of biologics processes.
Education and Essential Experience
  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied technical / engineering.
  • Experience with upstream cell culture and/or downstream purification of biological molecules.
  • Experience presenting in front of regulatory audits as SME.
  • Experience with tech transfer, regulatory filing and commercial drug substance manufacturing of biologics is a plus.
  • Technical operations experience in drug substance manufacture of biologics at commercial scale.
  • Experience in drug substance process development, process characterisation, PPQ and validation, site readiness, batch record reviews, regulatory CTD sections, and collaboration with CROs/CDMOs.
  • Experience in change management, deviations and CAPA management.
Seniority level
  • Associate
Employment type
  • Contract
Job function
  • Engineering, Quality Assurance, and Manufacturing
Industries
  • Pharmaceutical Manufacturing, Manufacturing, and Biotechnology Research

Note: This description reflects the responsibilities, qualifications, and expectations for the role without extraneous site notices or non-essential content.


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