Are you a process-driven engineer looking for an opportunity to support commercial manufacturing and process simulation in a cutting-edge biopharmaceutical facility?
We are hiring a Process Engineer to join a leading global pharmaceutical company at their state-of-the-art Carlow site.
This role offers a fast-paced, collaborative environment with exciting technical challenges in sterile manufacturing
About the Role:
The Process Engineer will be responsible for providing process, technical, and validation support for commercial manufacturing and process simulation development.
This role is key in ensuring compliance with cGMP and driving continuous improvement in manufacturing operations
Key Responsibilities:
Serve as technical support for manufacturing and new product introduction.
Design, review, and execute process simulation studies for new product introduction and ongoing manufacturing.
Provide technical input into quality notifications, investigations, and deviations.
Lead and participate in system failure investigations, root cause analysis, and CAPA implementation.
Support continuous improvement using Lean Six Sigma methodologies.
Execute and develop change controls to support process simulations.
Represent technical operations at global technical forums.
Ensure compliance with global policies, regulatory requirements, and cGMP.Work cross-functionally with internal teams and external vendors.
Drive a safety-first, compliance-driven culture.
What You Need to Succeed:
Degree qualified in Science, Engineering, or another technical discipline.
Experience in a sterile/aseptic manufacturing environment (preferred).Knowledge of sterile filling processes, equipment validation, and process simulations.
Experience with regulatory compliance, quality investigations, and risk management.
Strong problem-solving, troubleshooting, and data analysis skills.
Proficiency in Microsoft Office and job-related applications.
Ability to lead and influence cross-functional teams.
Strong communication, presentation, and project management skills.
Why Join?Work in a world-class biopharmaceutical facility.
Be part of an innovative, collaborative, and fast-paced team.
Opportunities for career growth and professional development.
Competitive salary and benefits package.
The Next Step for YouShould this position be of interest, please apply through LinkedIn with an up-to-date CV to Jessica from Next Generation Recruitment or call us on the main line at Next Generation are specialists in Supply Chain, Procurement, Engineering, Quality, Technical, and Operation positions (permanent, contract, and temporary).
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