Microbiologist I

Employer
CSL Behring
Location
Union, South Carolina
Posted
Oct 27, 2020
Ref
R-124567
Required Education
Bachelors Degree
Position Type
Full time
About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!

Job Description

Responsible for performing laboratory test procedures to support production in the process of approving product release; accountable to analyze and assess trends, recommend new or improved procedures including the thorough ,validation of new processes and on-going monitoring of systems and equipment. This position acts as sole authority to interpret results of product testing and determination of product disposition. Perform environmental monitoring of product manufacturing areas. Perform water sample collection and testing for bioburden, bacterial endotoxins and particulate matter. Perform bioburden testing for incoming raw materials, components, and in-process solutions (product testing). Perform bacterial endotoxin and particulate matter testing for incoming raw materials, components, and finished product. Performs sterility testing of finished product solution samples. Perform gram stain, biochemical testing and full identification testing on recovered microorganisms. Perform subculture maintenance on environmental isolates (and additional ID library organisms) Perform quality control testing on incoming media and reagents. Perform biological indicator (BI) verification qualification and support sterilization validation operations Perform general lab requirements (temp monitoring, autoclave runs, inventory tracking, ordering, equipment maintenance) Read, assess (analyze against known specifications) and process (ID submissions, initiate OOL investigations, alert/action level excursion notifications, etc.) all microbiological sample results, enter results in trending database. Ensure the complete and accurate documentation and reporting for all microbiological tests. Initiate and complete microbiological induced non-conforming events (NCEs). Support new product, equipment and process validation protocols and additional microbiology projects. Supports third party and internal audits as needed. Supports NCE Investigations and CAPAs / Change control projects as needed.

Bachelor degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry) Required

1-3 years' experience working in a cGMP regulated environment

Microbiology Laboratory experience required

Pharmaceutical of Medical Devise Testing experience preferred