Biomanufacturing Technical Lead
3 weeks ago
A career at Resilience US INC is an opportunity to shape the future of medicine production. We're a technology-driven biomanufacturing company revolutionizing the way medicines are made. Our goal is to create a sustainable network of cutting-edge manufacturing solutions that can withstand disruptions, serve scientific discovery, and reach those in need.
Job SummaryWe're seeking a skilled Biomanufacturing Technical Lead to join our team. This role will oversee improvement initiatives as the technical expert and serve as the first line of support for all project-related work. The successful candidate will maintain strong relationships with Technical Operations and Quality areas while collaborating with Manufacturing and Facility teams.
Key Responsibilities- Process Optimization: Ensure clear technical processes with defined centerlines, critical process parameters, material fit for use, and operating procedures deliver capable processes.
- Continuous Improvement: Lead efforts to reduce changeover time, improve yield, increase Overall Equipment Effectiveness (OEE), enhance maintenance reliability, and minimize waste for automated pharmaceutical manufacturing equipment.
- Technology Transfer and Validation: Ensure success criteria for technology transfer and validation are clear, and the process is capable for merging into the Manufacturing/Facility process.
- Protocol Generation: Create various URS, FAT, SAT, commissioning, and IQ/OQ/PQ protocols/reports.
- Manufacturing/Facility Improvement Initiatives: Coordinate and support initiatives defining equipment data, capabilities, utilization, efficiencies, and obsolescence, managing asset lifecycles, and maintaining external technical relationships.
To succeed in this role, you'll need:
- GMP or Regulated Production Experience: Proven track record in GMP or regulated production environments.
- Tech Skills: Training or experience in technologies like mechanics, hydraulics, pneumatics, vacuum technology, electronics, programmable logic controllers, HMI, Historian/reporting, computerized systems, vision systems, refrigeration, test equipment for electrical and mechanical troubleshooting, aseptic/controlled environment, unit operations, formulation, packaging, process validation, cleaning validation, technology transfer, change control.
The estimated salary for this position is around $120,000 - $160,000 per year, depending on location and qualifications.
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