Associate II, Manufacturing Operator (2nd Shift 2:00 pm to 10:30 pm)

MannKind Corporation•Danbury, CT

About The Position

The Associate II, Manufacturing Operator executes quality and manufacturing procedures to meet production demands and regulatory requirements, supporting the on-time manufacture of intermediate, semi-finished, and finished pharmaceutical products that meet quality standards. The role assists with equipment operating specifications, standard operating procedures, manufacturing technique improvements, equipment maintenance and calibration, and technical issue resolution. Working the 2nd shift from 2:00 pm to 10:30 pm, with a 10% shift differential, the Associate performs manufacturing operations in a clean room in accordance with Manufacturing Records, current Good Manufacturing Practices, and Standard Operating Procedures. Assignments are semi-routine and require some judgment to resolve problems and make routine recommendations within defined practices and policies. The employee may guide lower-level personnel and is expected to be qualified to operate approximately 50% of manufacturing equipment.

Requirements

High school diploma or GED.
For Associate II: 3 to 5 years of related experience, or an equivalent combination of experience and training.
Willingness and ability to receive medical clearance to wear a respirator, such as a Powered Air Purifying Respirator, for the entire working shift.
Physical ability to gown and de-gown, including use of a decontamination fogging shower, in up to three layers of clean-room and potent-compound-facility gowning, such as a Tyvek jumpsuit.

Responsibilities

Execute manufacturing operations according to Manufacturing Records, current Good Manufacturing Practices, and Standard Operating Procedures in a clean room environment.
Perform manufacturing area and equipment setup, cleanup, teardown, and sanitization under supervision.
Operate manufacturing production equipment under supervision as required by Manufacturing Records and Standard Operating Procedures.
Perform in-process inspections and testing under supervision as required by Manufacturing Records and Standard Operating Procedures.
Accurately and completely document manufacturing activities in Manufacturing Records, Controlled Forms, Product Container Labels, and Logbooks.
Verify and document that manufacturing steps performed by other Manufacturing Associates are correct in Manufacturing Records and/or Logbooks.
Observe Company, Health, Safety, and Environmental guidelines.
Assist with establishing equipment operating specifications and standard operating procedures, improving manufacturing techniques, maintaining and calibrating equipment, and resolving technical issues.
Provide guidance on assignments to lower-level personnel when needed.