Operations Management

Aseptic Operator

Position Summary:

The contents contained in this job description are the minimum requirements required to be met for the aforementioned position. Under the direction of area management or designee, the Aseptic Operator is responsible for performing all necessary tasks both in and outside of the classified manufacturing suites in support of manufacture of safe and effective sterile (injectable) pharmaceutical products.

Key Responsibilities:

Perform job functions with in compliance of 21CFR part 210 and 211, FDA, OSHA and other regulatory agencies.

Ensure that the current requirements for Environmental, Health, Safety (EHS) issues are met within the production operations.

Ensure training compliance for assigned curriculum prior to performing any work task

Set-up, Operation, and troubleshooting of key manufacturing equipment: including (but not limited to) lyophilizer, autoclave, parts washers, filler, capper, CIP/SIP skid, etc.

Documentation of perform tasks as per established Good Documentation Practices, and review of executed documentation (batch records, logbooks, etc.) prior to the end of the shift. 

Assist in the execution of equipment/process qualification, validation, and protocols as required.

Requirements:

HS Diploma/GED and 6+ years applicable experience required

Bachelor’s Degree or Military service highly desirable

Advanced computer skills proficiency preferred

Automation and controls experience preferred

Demonstrated mechanical troubleshooting preferred

Location 

Midwest

Consultant 

Andy Ellis