Urgent Senior Process Engineer MS&T

3 weeks ago

Dublin Pike, Ireland RT.Lane 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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