Process Expert and Project Manager
Vor 2 Tagen
Job Overview
Key ResponsibilitiesThe Senior Manufacturing Specialist will be responsible for providing technical and scientific support to manufacturing shopfloor operations, including:
- Managing MFG activities, including compliance, TT, campaign preparation, and troubleshooting.
- Providing expert guidance on manufacturing equipment and processes.
- Authoring technical instructions and records, including procedures, work instructions, and forms.
- Participating in tech transfer activities and ensuring manufacturing instructions are clear, safe, and compliant.
- Driving continuous improvement and managing Manufacturing focused Change Controls, CAPAs, and Manufacturing, Sciences, Planned Exceptions.
- Education: High school diploma (minimum) or a Bachelor's degree (preferred) in a scientific field.
- Experience: At least 8 years in GMP-regulated environments.
- Knowledge & Skills:
- High ability to interact with a cross-functional team effectively within organization.
- Very detail-oriented with excellent documentation skills.
- Coaching and Trainer skills for Manufacturing related activities.
- Deputy function for MTO Manager role.
- High knowledge of business and manufacturing processes to support manufacturing operations.
- High knowledge of Manufacturing Systems.
- Very good understanding of basic QA and cGMP principles.
- Very good level of technical writing skills.
- Very good skills in Microsoft Office.
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