Manufacturing Associate 3 (Filling)
Location:
Thousand Oaks , California
Posted:
November 22, 2016
Reference:
5009DW


Description
Summary
The Manufacturing Associate III is responsible for executing all manufacturing department processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations that could apply. In addition to making routine revisions to documents, this position may rewrite complex procedures or initiate new procedures as applicable. The incumbent has enough applied technical knowledge to perform complex trouble shooting tasks and may even assist during the transfer of new technologies into manufacturing. This position has sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills. All of the specific requirements presented in this job description are applicable to the functional area in which it resides

Essential Duties & Responsibilities

Formulation/Filling:
•Participate in bulk formulation, aseptic filling, Lyophilization, and capping operations.
•Executes processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply.
•Clean, Set up, operate, and teardown of equipment such as, tanks, filtration systems, filling lines, lyophilizers, etc.
•Operate general production equipment such as an autoclave, filter integrity testers, temperature probes, pH and conductivity meters, CIP skids, etc.
•Receive and distribute supplies into the manufacturing areas.
•May perform other duties as assigned.

Qualifications

Summary
The Manufacturing Associate III is responsible for executing all manufacturing department processes while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations that could apply. In addition to making routine revisions to documents, this position may rewrite complex procedures or initiate new procedures as applicable. The incumbent has enough applied technical knowledge to perform complex trouble shooting tasks and may even assist during the transfer of new technologies into manufacturing. This position has sufficient technical and administrative competence to organize and lead production activities, including demonstrating leadership in state-of-the-art cGMP compliance, and environmental health and safety skills. All of the specific requirements presented in this job description are applicable to the functional area in which it resides

Essential Duties & Responsibilities

Formulation/Filling:
•Participate in bulk formulation, aseptic filling, Lyophilization, and capping operations.
•Executes processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply.
•Clean, Set up, operate, and teardown of equipment such as, tanks, filtration systems, filling lines, lyophilizers, etc.
•Operate general production equipment such as an autoclave, filter integrity testers, temperature probes, pH and conductivity meters, CIP skids, etc.
•Receive and distribute supplies into the manufacturing areas.
•May perform other duties as assigned.

Equal Employment Opportunity
Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law
EEO is the law - Supplement
Pay Transparency Policy
Reasonable Accommodations
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.

A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.

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