Summary
Our client, a biopharmaceutical company in Co.
Dublin, is seeking a Process Engineer (MS&T).
The ideal candidate will deliver a range of technical support to the Drug Substance Business: leading technical investigations within the Integrated Process Team, supporting significant projects across the site, supporting design, construction and qualification of upstream & downstream equipment (when applicable), NPI/technology transfer and commercialisation at our client's site.
Responsibilities
Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements, and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
Design/Author/Review/Approve/Execute qualification documentation in line with the standard process.
Leads experimental design of studies, execution, data analysis and interpretation.
Authors and reviews batch documentation, regulatory and technical documentation
Interpret trends observed in commercial process monitoring (e.g., proactive process analysis (PPA), continued process verification (CPV), statistical process control (SPC), multivariate analyses (MVDA)), and for further technical investigations and process changes that seek to drive improvements to yield and/or robustness.
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 various site initiatives to improve compliance status and overall operational efficiency of the site.
Serve as a key member during internal audits and external inspections/audits
Lead and support various MS&T organisational initiatives as needed (examples include safety, financial forecasting, and work standardisation).
Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.
Qualifications & Experience
Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification
Experience leading technical-related projects.
Experience with upstream cell culture and/or downstream purification of biological molecules.
Experience in preparing for and presenting in front of regulatory audits as SME.
Experience with technology transfer, regulatory filing and commercial drug substance manufacturing of biologics is a plus.
Technical operations experience in the drug substance manufacture of biological molecules at commercial scale.
Prior experience in drug substance process development, process characterisation studies, process performance qualification and validation, site readiness, batch record reviews, authoring regulatory CTD sections and/or working with external contract organisation for development and/or manufacturing.
Experience in change management, deviations and CAPAs management.
SME in upstream/downstream processing and process control strategies.
Working knowledge of analytics.
Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment.
Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
Evidence of continuous professional development.
Technical writing skills.
Ability to effectively articulate understanding of biologics processes, in order to drive decision making, impact assessments, design of studies, etc., in a multi-disciplinary team environment.
Working knowledge of statistical process control (SPC), multivariate analysis (MVDA), and/or process analytical technologies (PAT) techniques for biologics processes.
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