Description:

Job Responsibilities

1. Perform environmental monitoring of the cleanroom, including sampling of viable surfaces, viable air and non-viable particulates

2. Conduct routine sampling and testing of WFI for bioburden and endotoxin

3. Conduct bioburden testing on prepared buffers/solutions, in-process samples, and drug substance

4. Perform personnel monitoring during critical processes

5. Conduct microbiological assays to support Quality Operations

6. Perform growth promotion, gram stains, and enumeration of viable samples.

7. Assist in trending environmental monitoring data

8. Report and investigate any monitoring excursions

9. Assist with method verification of samples for bioburden and endotoxin analysis

10. Generates new/revises Standard Operating Procedures for Environmental Monitoring and Microbiology procedures

11. Identifies adverse microbial quality trends by preparing and analyzing EM summary reports

Skills:

gmp, cleanroom, bioburden, qc testing, endotoxin, microbiology, aseptic technique

Additional Skills & Qualifications:

Job Requirements

1. Possess a BS/MS in Biology, Biochemistry, Chemical Engineering, or a related field

2. Possess 4-7 years of relevant experience in microbiology or environmental testing

3. Experience with aseptic technique preferred

4. Demonstrate attention to detail and ability to work within an interdisciplinary team environment

5. Ability to manage multiple tasks concurrently and drive tasks to completion in a timely manner

6. Desire to learn new techniques

Experience Level:

Expert Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.