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About this opportunity :

As a Manufacturing Technician III, you'll be responsible for the implementation of assigned production operations working within defined production schedules in a cGMP environment. This is a swing shift position which runs from 8:00 AM - 8:00 PM (1st week M,T and F - Sn / 2nd week W-Th). This role comes with a 5% shift differential.

Key Responsibilities:

+ May specialize in either purification or synthesis processes.

+ As required, may cross train on basic or non-technical operations associated with other functions within the company.

+ Maintain a clean and organized work environment in accordance with defined procedures.

+ Assist Process Support Group in the execution of special projects and data collection.

+ Demonstrate proficiency on the execution of key manufacturing processes which may include all or portions of the following: synthesis, cleavage and deprotection, chromatography, ultrafiltration , or freeze-drying

+ Qualify lower levels on key manufacturing processes.

+ May act as a lead for any given campaign.

+ Review of basic cGMP documentation including solution and raw material reconciliation.

+ Develop, review and revise SOPs and PIs to assure documentation reflects current operations.

+ Qualify on basic investigational documentation including OOT, SHE, and CAPA's.

+ Revise generic documentation to keep up with industry standards and customer expectations.

Required Skills/Abilities:

+ Minimum education requires high school diploma or equivalent with college level chemistry or equivalent work experience. A biotechnology certificate or college degree is preferred.

+ Must have knowledge of basic laboratory instrumentation such as use of pH meter, UV instrumentation, and solution delivery systems (process skids).

+ Must have knowledge of relevant manufacturing processes which may include chemical synthesis, chromatography, ultrafiltration, freeze-drying, and aseptic technique.

+ Experience in cGMP manufacturing environment.