Sterile Manufacturing Technician

• Perform recombination and pooling of drug substance
• Perform filling line set-up and sterile filling operations, equipment and line changeovers, and sampling
• Operate the parts washer and autoclave
• Perform root cause analysis of equipment and process problems, and implementing effective solutions, including preventive and/or corrective actions
• Complete both the manufacturing and visual inspection of sterile drug product
• Write, update and execute Batch Records, SOPs and other GMP Documentation
• Complete detailed batch record and GMP documentation entries
• Perform environmental monitoring and routine batch sampling
• Perform housekeeping duties
• Maintain an exemplary personal training record
• Pro-actively identifies compliance risks and takes appropriate preventative actions
• Proactively identify equipment issues and perform root cause analysis
• Proactively lead and support continuous improvement initiatives
• Provide leadership and guidance on shift
• Support investigations into Quality events, including reporting production issues, writing reports and implementing CAPAs
• Participate in/Lead cross functional team initiatives
• Participate & support site inspections by regulatory agencies
• Demonstrate commitment to a high level of safety awareness
• Execute all operations activities in a safe manner and in strict accordance to SOPs, cGMP regulations and site Quality standards
• Support Sterile filling equipment commissioning and qualification
• Interface with external vendors & service providers

• Previous experience in a highly regulated sterile filling facility
• Previous experience of syringe and vial sterile filling and visual inspection is highly desirable
• A high mechanical aptitude and capability is desired along with technical experience
• Candidates that can demonstrate a keen sense of focus and attention to detail when fulfilling exacting and repetitious tasks
• Must be conscientious and possess strong teamwork and interpersonal skills
• Strong communication and problem-solving skills
• Demonstrated leadership skills in preferred

Previous experience in a leadership role or senior technician role