Manufacturing Engineer Lead
4 days ago
RT Lane Recruitment is currently recruiting for a skilled Process Engineer to join the Process Engineering Group on site and report to the Technical Engineering Manager.
This individual will serve as technical support for new product introduction (NPI) and commercial manufacturing, participating in or leading cross-functional or single-function teams.
The ideal candidate will have prior related work experience, preferably in a GMP setting, with knowledge of process monitoring systems, automation systems, operational intelligence & data systems within a GMP manufacturing environment.
The role involves design, authoring, reviewing, approving, and executing qualification/validation documentation and process development studies in line with the standard approval process. Additional responsibilities include designing, authoring, reviewing, approving, and executing change controls, contributing to Kaizen events, providing technical input into quality notifications, and supporting continuous improvement through Lean Six Sigma methodologies.
Key Requirements:
- Bachelor's Degree or higher preferred in a Science, Engineering, or other technical discipline.
- Minimum 3 years' experience ideally in manufacturing, preferably in a GMP setting.
- Demonstrable experience of leading technical-related projects.
- Knowledge of regulatory/code requirements to Irish, European, and International Codes, Standards, and Practices.
- Report, standards, and policy writing skills required.
- Equipment and process validation experience.
- Sterile filling processes and equipment knowledge.
- Proficiency in Microsoft Office and job-related computer applications required.
- Excellent communication, presentation, and interpersonal skills to interface effectively with all levels of colleagues and with external customers in a team-oriented manner.
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