Pharmaceutics International, Inc. (Pii), a Jabil company, has an exciting opportunity for an experienced Quality Control (QC) Microbiologist to join our pharmaceutical team in Hunt Valley, MD! 

Pii provides CDMO solutions specializing in aseptic manufacturing, oral dosage forms, and accelerated drug development. Together, Jabil and Pii offer truly end-to-end pharmaceutical solutions.

Shift: 3rd Shift Sun-Thur 11p-7:30a +overtime as needed including weekends

Local candidates preferred

Pay Rate $30-35/hr DOE + 15% shift differential

Multiple openings available

How will you make an impact?

The QC Microbiologist will play a critical role in ensuring the microbiological quality and compliance of raw materials, in-process samples, finished products, and the manufacturing environment in accordance with cGMP and regulatory standards.

What will you do?

• Provides QC microbiology support to the Aseptic Manufacturing and validation process.

• Performs Microbiological Tests and studies by following the established procedures referenced in the official sources.

• Collection of water samples for testing (WFI, DI, Raw)

• Collection of samples (Raw Materials, Excipients, Validation, In-process and Finished product samples) for microbiological/chemical testing.

• Conducts validations studies and routine tests related to Bioburden Tests, Bacterial Endotoxin Tests, Particulate Matter Test, and Sterility Tests.

• Preparation of microbiological media and diluents by following laboratory procedures.

• Quality Control Testing of microbiological media and reagents.

• Environment Monitoring of Aseptic / Non-aseptic Manufacturing areas and Trending of microbial data obtained from EM/Utilities/Raw Materials/In-process and finished products testing and preparing the periodical summary report.

• Maintenance of Laboratory inventory and cleanliness of the Laboratory.

• Responsible for maintaining the microbiology isolates obtained from EM and Utility Monitoring Program.

• Follow established health and safety procedures and policies related to QC Microbiology Laboratory operations. Perform other related duties as required and assigned by Microbiology Laboratory Management.

• Perform other duties as assigned.

How will you get here?

Education and Experience:

• High School or equivalent required.  Associate’s or Bachelor’s degree in Microbiology, other related life science preferred.

• 1-3 years of relevant experience working in cGMP cleanroom and QC microbiology or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.

• Experience in a Pharmaceutical manufacturing environment desired

• Must be comfortable with varying levels of aseptic techniques

• Strong understanding of cGMP, USP, EP, and regulatory requirements for microbiological testing.

• Familiarity with rapid microbiological methods and modern instrumentation (e.g., endotoxin testing systems, automated identification systems).

Knowledge, Skills, Abilities:

• Excellent attention to detail and documentation practices

• Must be able to comprehend and follow all applicable SOPs.

• Demonstrate ability to acquire the appropriate knowledge from resources on electronic Quality Management Systems such as MasterControl and Trackwise.

• Demonstrate the ability to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.

• Good understanding of cGMPs, industry, and regulatory standards and guidelines.

• Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.

• Demonstrate literacy and ability to use data acquisition and processing software.

• Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.

• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.

• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.

• Must be able to comprehend and follow all applicable SOPs.

• Strong written and verbal communication skills with legible handwriting.