Manufacturing Technical Specialist
3 weeks ago
This senior role is responsible for providing technical support to all manufacturing operations at NOWDiagnostics | NOWDx. The successful candidate will be knowledgeable of the chemistry and equipment aspects of all assigned processes and will take charge with projects and direct as needed when working with contractors and employees.
Responsibilities:
- Provide technical support to all manufacturing processes, including equipment maintenance, qualification, process improvement, and troubleshooting.
- Develop manufacturing processes in conjunction with technology transfer from development and process improvement projects.
- Write, review, and approve manufacturing Standard Operating Procedures (SOP), Work Instructions (WI), Batch Records (BR), etc.
- Train others on BRs, SOPs, WIs.
- Daily monitoring of all ongoing processes to ensure compliance with Master Batch Records and cGMPs.
- Recommend, specify, and order equipment and parts.
- Coordinate repairs to equipment and facility.
- Draft and execute equipment IQ, OQ, and PQ.
- Keep equipment in maintained and ready-for-use state.
- Participate in project scheduling activities along with all applicable departments.
- Training of personnel with regards to applicable processes, equipment, standard operating procedures (SOPs), internal procedures, etc.
- Participate in safety processes and meetings as applicable.
- Make recommendations with regards to manufacturing processes, facilities, safety, and hazardous material handling.
- Head install projects and asset placement for best process organization.
Requirements:
- 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:
- BSc degree in science or engineering.
- 2 years of related work experience.
This position is not an IT/Technical position.
No relocation fees/moving costs included.
No sponsorship included.
This job description is not a comprehensive or exhaustive list of the responsibilities and requirements of the position.
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