Our Ideal Candidate
Job Description:
* Design and implement qualification/validation documentation for process development studies, adhering to standard approval processes.
* Develop change controls and contribute to Kaizen events as necessary.
* Provide technical input into quality notifications by authoring, reviewing, and approving investigations.
* Execute equipment qualification validation programs, including requalification and revalidation.
* Support continuous improvement through Lean Six Sigma methodologies.
* Analyze system failures using standard tools and methods to resolve machine and system issues.
Requirements and Qualifications:
* Bachelor's Degree or higher in a Science, Engineering, or Technical discipline.
* Minimum 3 years of experience in manufacturing, preferably in a GMP setting.
* Experience in leading technical projects with evidence of continuous professional development.
* Knowledge of process monitoring systems, automation systems, and data systems within a GMP manufacturing environment is beneficial.