About this role
Description About you:
In this technical production role, you will be responsible for the manufacture and assembly of consumable components for the Vital Bio medical diagnostic platform from raw materials through to the final packaged product. The primary focus of the role will be with the ongoing scale-up of the manufacturing process. As a member of the Manufacturing team you will be an integral part of Vital Bio?s efforts to launch commercial production of the company?s innovative medical diagnostic technology.
Working directly with all supporting functions, this role will apply well defined processes through work instructions, batch production records, manufacturing aids to generate products intended for commercial distribution.
What You?ll Do:
• Setup, prepare, and execute processes with high quality and consistency which generate products meeting specifications as intended for commercial use, including: o Build of consumable assemblies o Dispense of liquid formulations o Lyophilization, bead sieving and sorting o Disc assembly o Packaging
• Generate and complete all associated documentation using current Good Documentation Practices (GDP) including Batch Production Records; • Maintain accurate records of production, including taking inventory of production and prototype materials through cycle counting and physical inventories; • Set up, operate, and monitor automated and semi-automated equipment used in the assembly process; • Collaborate in the development, setup, and maintenance of cGMP processes at production scale; • Provide feedback and recommendations to the manufacturing engineering team for improvements to manufacturing work instructions, assembly, and test fixtures and processes • Provide feedback and recommendations to supervisors and JH&S Committee regarding Health & Safety concerns/near-misses/incidents; • Apply 5S and lean principles to maintain organization and good housekeeping practices in the manufacturing area; • Work with associated development and engineering teams to incorporate improvements into the manufacturing process based on testing results and observations; • Participate in process FMEAs and risk identification as well as assisting with the implementation of appropriate countermeasures; • Assist Manufacturing Engineering in the setup and validation of new equipment for use in the assembly process; • Execute daily, weekly, and monthly preventive maintenance and cleaning activities of equipment and manufacturing areas; • Support and participate in root cause investigations for, Out-of-Specification (OOS) investigations, Quality Incident Notifications, and CAPA actions related to manufactured products and manufacturing processes; • Maintain a high level of work-related training to ensure consistency of performance, including cross-training on multiple processes within Manufacturing;
What You?ll Need:
• High school diploma or higher; • 3+ years of industry experience in medical device or electronic assembly, preferably in a cGMP environment; • Very good manual dexterity and visual acuity; • Ability to read and understand written assembly and test instructions; • Demonstrated strong organizational skills in your day-to-day performance and ability to multitask across projects and activities; • Excellent communication skills and attention to detail; • Proven ability to collaborate cross-functionally and participate in multi-disciplinary teams. Bonus points for:
• Experience with reagent preparation, operation of (semi-)automated manufacturing systems • Experience with 5S, kanbans, and lean manufacturing processes; • Prior experience with single-use