Associate II, Chemical Operator M-F, 7am - 3:30pm

MannKind Corporation•Danbury, CT

9d•Onsite

About The Position

At MannKind, employees are our number one asset, and we are building a tight-knit community where each of us plays a critical role in our collective success. Committed to diversity, MannKind depends on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better. This role executes quality and manufacturing procedures to meet production demands and regulatory requirements. Responsibilities include the on-time manufacture of intermediate, semi-finished, and finished pharmaceutical products that meet quality standards. The position assists with establishing equipment operating specifications, standard operating procedures, and improving manufacturing techniques. It also assists with equipment maintenance, calibration, and resolving technical issues. The role may review existing manufacturing operational processes and procedures and provide technical expertise to improve production efficiencies. The shift is Monday - Friday from 7:00 am – 3:30 pm.

Requirements

Must have experience working with chemicals and batching.
High School diploma/GED with minimum of 6 - 8 years related experience or the equivalent combination of experience and training.
Experience writing and implementing SOPs in a GMP environment.
Must be willing and able to receive medical clearance to wear a respirator (i.e., Powered Air Purifying Respirator) for entire working shift.
Must be physically able to gown and de-gown (including the use of a decontamination fogging shower) in up to three layers of clean room and potent compound facility gowning (i.e., Tyvek® jumpsuit).

Nice To Haves

May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.
May review existing manufacturing operational processes and procedures and provide technical expertise in order to improve production efficiencies.

Responsibilities

Works on assignments where considerable judgment and initiative are required in resolving problems and making recommendations.
Exercises independent judgment evaluating criteria for obtaining results.
Executes manufacturing operations as required by Manufacturing Records according to Current Good Manufacturing Practices and Standard Operating Procedures in a clean room environment.
Operates manufacturing production equipment, under little supervision as required by Manufacturing Records and Standard Operating Procedures.
Performs manufacturing area and equipment setup, cleanup, teardown and sanitization with little supervision.
Performs in-process inspection and testing, under little supervision, as required by Manufacturing Records and Standard Operating Procedures.
Accurately and completely documents manufacturing activities in appropriate Manufacturing Records, Controlled Forms, Product Container Labels and Logbooks.
Verifies and documents manufacturing steps performed by other Manufacturing Associates as correct in Manufacturing Records and / or Logbooks.
Responsible for observing all Company, Health, Safety and Environmental guidelines.
Fully qualified and able to operate approximately 75% of manufacturing area equipment.