Lead Manufacturing Tech

Donaldson - Durham, NC

Full-time - Mid Level

Durham, NC

Computer and Electronic Product Manufacturing

About the position

The Lead Manufacturing Technician at Donaldson plays a crucial role in executing and documenting daily manufacturing operations within a cGMP environment. This position is responsible for operating process equipment, ensuring compliance with cGMP standards, and maintaining equipment and facilities. The technician collaborates closely with the Manager to coordinate critical activities and efficiently utilize resources, contributing to the development and commercialization of innovative bioprocessing solutions.

Responsibilities

• Executes manufacturing processing steps and/or manufacturing support activities, monitoring the process against the batch record and DOT compliance system.
• Coordinates and/or leads process steps as required, serving as a process step(s) expert.
• Manufacturing steps for upstream and downstream purification including fermentation, buffer prep, homogenization, chromatography, ultrafiltration, sterile filtration, and filling.
• Schedules tasks for a given shift and plans resource allocation in coordination with the Manager.
• Documents/records and reviews cGMP data and information, including documentation of deviations for processing steps and/or equipment activities.
• Develops and/or revises documents as needed, including batch records and equipment logbooks.
• Actively participates in training activities and manages their own individual training plan.
• Provides training to other associates and shares knowledge with others.
• Observes performance of employees, provides timely and targeted coaching, and gives feedback to the Manager.
• Initiates/investigates deviations and develops and implements corrective and preventative actions as required.

Requirements

• Associates Degree in a technical field or biotechnology certification from an accredited program
• 3 or more years of biomanufacturing experience
• Knowledge of policies/standards (cGMP, ISO 9001/13485, 21CFR820)

Nice-to-haves

• Experience with upstream and/or downstream manufacturing processes in a clean room GMP facility
• Experience with fermentation, separations, and purification processes, including chromatography, ultrafiltration, and centrifugation
• Experience in Clean-in-Place and/or Sterilization-in-Place systems
• Highly detail-oriented with excellent documentation skills and exceptional troubleshooting abilities

Benefits

• Full-time position with competitive salary
• Opportunities for professional development and training
• Collaborative work environment
• Contributions to meaningful projects in biotechnology