Manufacturing Operations Technician
4 weeks ago
Location: Providence, RI (onsite)
Schedule: 1st Shift (6:00am - 2:30pm)
Duration: 6-Month Contract (opportunity to extend)
Pay range: $22.00 - $26.00 per hour
This role focuses on the fabrication of cell encapsulation devices for delivering specialized cells, including the manufacturing of all components and final assembly of the finished device. The successful candidate will join the Device Manufacturing Team and collaborate closely with Device Process Development, Device Quality Control, and Device Quality Assurance functions as needed.
Key Responsibilities:
- Perform daily maintenance and startup activities for all manufacturing unit operations.
- Manufacture and assemble medical devices in an ISO 7/8 cleanroom environment, ensuring compliance with cGMP procedures and cleanroom practices in each unit operation.
- Complete and compile batch records in accordance with cGMPs, cGDPs, and relevant procedures.
- Adhere to all company policies, including health, safety, and environmental regulations, personal protective equipment requirements, and standard operating procedures.
- Maintain the manufacturing areas to ensure a clean, safe, and organized work environment.
- Review and train on work instructions and other relevant documents as needed.
- Prioritize and plan work activities, adapting to changing production schedules and other conditions as required.
- Participate in process capability assessments, process validation activities, root cause investigations, corrective and preventative actions, physical inventory, cycle counts, variance investigation and reconciliation, and other cross-functional activities as needed.
- Review all manufacturing documentation, including assembly, inspection, test, and packaging procedures, and provide feedback.
Required Qualifications:
- High school diploma or equivalent; technical education preferred.
- 2+ years of manufacturing experience in a medical device or other regulated environment, with a strong understanding of cGMPs.
- Manual dexterity for handling tools and equipment of varying sizes.
- Excellent verbal and written communication skills, with strong English reading and writing abilities.
- Proven ability to monitor and ensure the quality, accuracy, and thoroughness of work; self-motivated and able to work independently or as part of a team.
- Ability to work in a fast-paced environment, multitask, and adapt to changing work environments and priorities.
- Willingness to work overtime, extended hours, and weekends as required.
- Familiarity with the assembly of small, intricate components, often requiring microscopic guidance.
- Experience with ERP, laboratory information management systems, or similar systems is a plus.
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