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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