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Manufacturing Specialist
hace 2 meses
Mentor Technical Group is seeking a highly skilled Manufacturing Specialist to join our team. As a key member of our manufacturing operations team, you will be responsible for supporting the execution of manufacturing/quality systems, including non-conformances, process validation, procedures, training, and new product introductions.
Key Responsibilities- Apply process, operational, scientific expertise, and analytical and troubleshooting skills to support manufacturing operations.
- Assess process performance by observation of floor operations and review of performance data.
- Provide troubleshooting support and assist in generation of training materials.
- Support establishment of process monitoring parameters and control limits.
- Ensure timely execution of process monitoring quarterly reports.
- Responsible for authoring investigation reports and execution of corrective actions.
- Assist with generation of process validation protocols and reports.
- Participate in regulatory inspections and new product introductions.
- Doctorate degree OR Master's degree and 3 years of Manufacturing Operations experience OR Bachelor's degree and 5 years of Manufacturing Operations experience or Associate's degree and 10 years of Manufacturing Operations experience or High school diploma / GED and 12 years of Manufacturing Operations experience.
- Detailed technical understanding of bioprocessing unit operations.
- Skilled in performance of GMP production operations.
- Regulatory knowledge and interactions.
- Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality.
Mentor Technical Group is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.