Manufacturing Technical Specialist
1 week ago
Job Title: Manufacturing Technical Specialist
Department: Manufacturing
Reports To: Manufacturing Engineering Manager
Key Responsibilities:
- Provide technical support to all manufacturing processes, ensuring compliance with Master Batch Records and cGMPs.
- Develop and implement 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, and ensure they are knowledgeable of the chemistry and equipment aspects of all assigned processes.
- Recommend, specify, and order equipment and parts, and coordinate repairs to equipment and facility.
- Draft and execute equipment IQ, OQ, and PQ, and keep equipment in a maintained and ready-for-use state.
- Participate in project scheduling activities and training of personnel with regards to applicable processes, equipment, standard operating procedures (SOPs), internal procedures, etc.
- 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.
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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