Manufacturing Process Specialist
Vor 2 Tagen
Job Description
Overview of the RoleThe Senior Manufacturing Specialist will be responsible for providing technical and scientific support to manufacturing shopfloor operations.
Key Responsibilities:
- Manage timely completion of MFG activities, including compliance, TT, campaign preparation, troubleshooting, coaching of MAs, and process equipment management.
- Oversee and manage intra, cross-site, and cross-functional projects related to process and productivity improvements.
- Act as Subject Matter Expert on manufacturing equipment and processes, participating in tech transfer activities and authoring related technical instructions.
- Partner with direct manager to assign resources to tech transfers, drive continuous improvement, and ensure manufacturing instructions are clear, safe, and compliant.
- Initiate, own, and manage 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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