Process Engineer – MS&T (Hybrid)
RK23803
11 Months
Dublin



We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.




The MS&T Process Engineer delivers 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



Key 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 organizational initiatives as needed (examples include safety, financial forecasting, work standardization, etc).
• Maintain continuous focus on quality and safety compliance and unflinching focus on the customer.

• Bachelor degree in a scientific or engineering field
• Minimum 5 years of relevant post-degree work experience in GMP Manufacturing
• 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 organization for development and/or manufacturing.
• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment.
• SME in upstream/downstream processing and process control strategies.