Senior Manufacturing Technician, Consumables Manufacturing

The Senior Manufacturing Technician is responsible for manufacturing in vitro diagnostic (IVD) consumable components and kits in a cGMP regulated environment. This position supports consumable production operations through aseptic filling, equipment setup and maintenance, production support, documentation, inventory management, and quality compliant manufacturing practices.

The role serves as an experienced manufacturing resource for consumable filling processes and supports production of new and existing products on the existing Wave card manufacturing line, including implementation of approved equipment and process changes required for manufacturing operations.

• Manufacture IVD consumable components and kits in accordance with approved procedures, cGMP requirements, and quality standards.
• Perform consumable manufacturing activities including aseptic filling, component preparation, equipment setup, labeling, packaging, lot yield verification, and production record completion.
• Set up, operate, maintain, troubleshoot, and support filling equipment and associated manufacturing systems used in consumable production.
• Support manufacturing activities for existing and new products produced on the Wave card manufacturing line, including implementation of approved equipment modifications, process changes, and production readiness activities.
• Identify, document, and communicate manufacturing, equipment, and process-related issues; assist with troubleshooting activities; and support quality and manufacturing investigations and corrective action activities as required.
• Provide guidance to manufacturing personnel regarding established procedures, equipment operation, and manufacturing practices, and assist with training activities as assigned.
• Create, revise, and maintain manufacturing documentation including work instructions, equipment procedures, and production records in accordance with Good Documentation Practices (GDP).
• Manage manufacturing materials and inventory, including Kanban replenishment, material transactions, issuance activities, inventory reconciliation, and movement of materials through applicable business systems.
• Perform and support equipment maintenance activities including routine upkeep, preventive maintenance, calibration tracking, and maintenance documentation.
• Train and mentor technicians and other manufacturing personnel on established manufacturing processes, procedures, and equipment operation.
• Perform other duties as assigned.

• High school diploma or equivalent required.
• Associate degree in a technical, scientific, engineering technology, manufacturing technology, or related discipline preferred.
• Equivalent combinations of education, technical training, and related work experience will be considered in lieu of formal education.

• Minimum 5 years of experience in regulated manufacturing required. Experience in in vitro diagnostic (IVD), medical device, biotechnology, pharmaceutical, or other cGMP manufacturing environments preferred.
• Experience with aseptic manufacturing processes, liquid filling operations, consumable manufacturing, or automated production equipment strongly preferred.

• Working knowledge of Current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), manufacturing procedures, equipment operation, and safety requirements in a regulated manufacturing environment.
• Knowledge of basic biology and microbiology principles applicable to IVD, biotechnology, medical device, or life science manufacturing.
• Working knowledge of manufacturing troubleshooting techniques and the ability to assist with investigation of equipment, process, and product quality issues.
• Experience supporting process improvements, manufacturing investigations, and implementation of new products in a regulated manufacturing environment.
• Strong written and verbal communication skills, including the ability to prepare technical documentation, communicate effectively with cross-functional teams, and train others.
• Ability to perform assigned work with minimal day-to-day supervision while following established procedures, priorities, and departmental guidance.
• Ability to collaborate effectively with Quality, Engineering, Supply Chain, and external suppliers.
• Strong organizational, planning, time-management, and recordkeeping skills with a high level of attention to detail and accuracy.
• Basic mathematical skills…