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Clean Room Supervisor/Operator

Providence, RI 02905

Posted: 03/15/2023 Employment Type: Contract Job Category: Production Job Number: 544138 Is job remote?: No Country: United States

Job Description

Device Synthesis Contractor Role is seeking a Cleanroom Supervisor to join the Device Synthesis group within Research & Development supporting the Type 1 Diabetes program. This role will report to the Senior Manager and work closely with them to supervise a small team that supports prototyping and manufacturing of all components and assembly of a novel cell-encapsulation device. The individual will have strong leadership skills and be required to work on multiple projects in a fast-paced environment where communication and organization will be critical. This position will also utilize a variety of analytical tools as well as perform a variety of laboratory procedures according to prescribed protocols which they will help to draft and maintain.

Key Responsibilities: • Manufacture and assemble medical device prototypes in an ISO 7/8 Environment, ensuring compliance with applicable standards. • Supervise a team of 2-4 technicians focused on prototyping and production of design concepts. • Work with Senior Manager to plan and coordinate daily tasks for technicians and activities of all prototyping operations with an ability to adapt to changing prototyping schedules and other dynamic priorities. • Work cross-functionally with management, facilities, and supply chain to maintain operations and materials for an ISO 8 R&D prototyping cleanroom. • Ability to provide timely feedback on designs, processes, and custom equipment used in routine prototyping, fabrication, and characterization. • Author, maintain, and train others to all relevant process documentation, including Assembly, Inspection, Testing/In-Process Characterization, and Packaging Procedures. • Review and approve Device History Records to ensure accuracy and enforce GDP. • Maintains a sterile environment in the clean room, by garbing and behaving according to clean room procedures that align with guidelines. • Comply with all Company Policies including Health, Safety, and Environmental Regulations, Personal Protective Equipment Requirements, and Standard Operating Procedures.

Minimum Qualifications: • Two-year degree in Engineering, Biotechnology/Pharmaceuticals, or relevant technical field. • 4-6 years’ experience in Manufacturing or Laboratory environment. • 1-3 years’ experience of supervisory experience. • Strong verbal and written communications skills with ability to effectively communicate with multiple teams. • Conflict management and interpersonal skills. • Familiarity with cGMPs, documentation using Batch Records and/or Device History Records in a manner that complies with cGMPs / cGDPs. • Ability to work in a fast-paced environment and multitask, comfortable with changing work environments and priorities. • Proven ability to monitor own work product, ensuring quality, accuracy, and thoroughness; able to self-motivate and work independently or as part of a larger team. • Manual dexterity to handle tools, and other equipment, of varying sizes.

Preferred Qualifications: • B.S. in Engineering, Biotechnology/Pharmaceuticals, or relevant technical field. • Experience in assembly of small, intricate Components under microscopic guidance. • Experience with Six Sigma, Design for Manufacturability, and DMAIC. • Experience engineering implantable medical devices with GMPs.
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