Medical Device Operator II

Description:

The Medical Device Manufacturing Operator is responsible for performing manufacturing tasks for the production of commercial medical devices according to Standard Operating procedures, and cGMP regulations.

Essential Functions:

• Perform manufacturing operations in accordance with established work instructions.
• Manage multiple and varied responsibilities in a fast-paced manufacturing environment with minimal supervision
• Complete the set-up, operation, disassembly, and cleaning of process equipment according to standard operating procedures
• Operate laboratory instruments such as balances, pH meters, Microscope etc.
• Ensure that any issues that might impede the production schedule or quality standards are communicated through the proper channels.
• Execute and witness batch record instructions during cGMP operations.
• Document production activities according to GDPs in corresponding batch records and log sheets.

Education:

• High School or GED - Required

Experience:

• 1 year or more in pharmaceutical manufacturing

Skills:

• Experience in a manufacturing environment• Experience in an ISO environment• Detail oriented with good hand-eye coordination for working with small components• Must possess mechanical aptitude in order to work with precision equipment• Good written and verbal communication skills• Good record keeping skills• Ability to perform basic mathematical calculations• Experience in measurement methods and practices• Must be a team player• Must be able to wear required protective safety gear/equipment, including respirator mask - Advanced

Specialized Knowledge:

• Knowledge of GMP documentation and regulations• Basic computer skills including the ability to input data, prior experience with computerized control panels preferred• Ability to communicate verbally and read, comprehend and prepare documents in English• Able to lift and move equipment into place with and without assistance