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Senior Manufacturing Process Specialist
3 weeks ago
At a leading biopharmaceutical organization in Ireland, we are seeking an experienced Process Engineer to join our client's team. As a key member of the technical team, you will play a crucial role in ensuring compliance with regulatory requirements and best practices.
Key Responsibilities:- Develop qualification/validation documentation and process development studies in line with standard approval processes.
- Execute execution/development of change controls.
- Contribute to continuous improvement initiatives through Lean Six Sigma methodologies.
- Author investigations and root cause analyses of system failures.
- Support technical operations discussions and represent engineering expertise at global forums.
- Drive compliance with regulations and execute current Good manufacturing Practices (cGMP) in day-to-day activities.
- Ensure compliance via documentation completion, risk assessments, corrective action, and proactive issue identification.
Our ideal candidate will possess a Bachelor's Degree or higher in a Science, Engineering, or Technical discipline, with at least 3 years of experience in manufacturing. Demonstratable experience in leading technical-related projects and evidence of continuous professional development is desirable.
Requirements:- Bachelor's Degree or higher in a Science, Engineering, or Technical discipline.
- At least 3 years of experience in manufacturing, preferably in a GMP setting.
- Demonstratable experience in leading technical-related projects.
- Evidence of continuous professional development.
