Manufacturing Technical Expert
1 week ago
**About the Role:**
We are seeking a highly skilled Manufacturing Technical Specialist to join our team at NOWDiagnostics | NOWDx. As a key member of our manufacturing team, you will be responsible for providing technical support to all manufacturing processes, ensuring compliance with Master Batch Records and cGMPs.
Key Responsibilities:
- Technical Support: Provide technical support to all manufacturing processes, including equipment maintenance, equipment qualification, process improvement, and troubleshooting.
- Process Development: Develop manufacturing processes in conjunction with technology transfer from development and process improvement projects.
- Documentation: Write, review, and approve manufacturing Standard Operating Procedures (SOP), Work Instructions (WI), Batch Records (BR), etc.
- Training: Train others on BRs, SOPs, WIs, and other relevant documentation.
- Compliance: Daily monitoring of all ongoing processes to ensure compliance with Master Batch Records and cGMPs.
- Equipment Management: Recommend, specify, and order equipment and parts, and coordinate repairs to equipment and facility.
- Quality Assurance: Draft and execute equipment IQ, OQ, and PQ, and keep equipment in a maintained and ready-for-use state.
- Project Management: Participate in project scheduling activities along with all applicable departments.
- Training and Development: Train personnel on applicable processes, equipment, standard operating procedures (SOPs), internal procedures, etc.
- Safety and Compliance: Participate in safety processes and meetings as applicable, and make recommendations with regards to manufacturing processes, facilities, safety, and hazardous material handling.
- Asset Management: Head install projects and asset placement for best process organization.
Requirements:
- Education: BSc degree in a science or engineering.
- Technical Skills: Strong ability to read and interpret technical documents such as Scientific Publications, Operations Manuals, Equipment Schematics, Master Batch Records, Protocols, Standard Operating Procedures.
Preferred Qualifications:
- Education: MSc degree in a science or engineering.
- Experience: 2 years of related work experience.
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