Manufacturing Technical Specialist
3 days ago
Job Title: Manufacturing Technical Specialist
Department: Manufacturing
Reports To: Manufacturing Engineering Manager
Authorities:
- Manufacturing Document Revisions
- Manage Equipment and Facility Repair
- Quality Compliance
- Manufacturing Process Design
- Train Manufacturing Technicians
- Equipment Qualification IQ/OQ/PQ
Position Summary:
- The Manufacturing Technical Specialist is responsible for providing technical support to all manufacturing operations. They ensure that all manufacturing processes are designed and executed in a compliant and efficient manner.
Duties & Responsibilities:
- Provide technical support to all manufacturing processes
- 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
- Other applicable duties as assigned
Position 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
Education:
- BSc degree preferred
No relocation fees/moving costs included
No sponsorship included
This position is not an IT/Technical position
Note: This job description should not be construed to imply that these requirements are the exclusive standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as may be required by their supervisor.
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