Manufacturing Technician

Job summary
Provide daily support for all cGMP manufacturing activitiesPreparation of solutions, buffers, and cleaning equipmentFollow cGMP guidelines and ensure proper training
Job seniority: mid-to-senior level
Responsibilities
• Assist in preparation of solutions and buffers for the manufacturing process• Comply with SOPs and master batch record following GMP guidance• Familiar with Downstream manufacturing, depth filtration, TFF, and Final Fill• Assist with production process steps as needed• Clean and sanitize manufacturing vessels, equipment, and rooms• Write SOPs and other GxP documents• Assist with deviations, investigations, and CAPAs• Perform daily checks and calibrations of equipment• Review and document data with accuracy• Setup and execute projects independently• Troubleshoot and maintain process equipment• Display leadership characteristics• Strong communication skills• Work well in a team• Follow written and verbal direction
Requirements
• Experience making biologic solutions and buffers• Experience working in a cGMP aseptic environment (ISO 8 or 7)• Strong background in Single-Use technology• Worked in Downstream manufacturing, depth filtration, TFF, and Final Fill• HS or AS degree / BS a plus, not required• 8-10 years of Aseptic Manufacturing in GMP Pharma/Biotech company• High attention to detail• Proven documentation skills• Dedication to production quality• Experience with production planning• Familiarity with equipment calibration techniques
Key Skills Needed
• Experience making biologic solutions and buffers• Strong background in Single-Use technology• Familiarity with equipment calibration techniques