Manufacturing Technical Specialist

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 1, 2, and 3
• Equipment Qualification IQ/OQ/PQ

Position Summary:  

• The Manufacturing Technical Specialist is responsible for technical support for all manufacturing operations. They provide support through equipment maintenance, equipment qualification, process improvement and troubleshooting, product performance troubleshooting, and training. They are responsible for ensuring that all manufacturing processes are designed and executed in a compliant and efficient manner. They are knowledgeable of the chemistry and equipment aspects of all assigned processes. They take charge with projects and direct as needed when working with contractors and employees.

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 (including daily, short term and long term) 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:  

• BSc degree in a science or engineering
• 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:  

• MSc degree in a science or engineering
• 2 years of related work experience

Education:  

• BSc degree in a science

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.