Microbiologist II

Piramal Pharma • Lexington, KY

6d

About The Position

The Microbiologist II performs microbiological testing of raw materials, work-in-process, and finished products to support product approval and release while maintaining compliance with laboratory standard operating procedures. The role develops microbiological test methods and validations, prepares related protocols and reports, and performs media growth promotion and bacterial culture maintenance. It supports investigation and resolution of nonconformance issues, environmental monitoring excursions, and other laboratory matters, documenting work in accordance with GMP/GLP requirements.

The position maintains laboratory instrumentation and cleanliness, assists with data review and SOP updates, coordinates with other departments and external vendors, and contributes to Quality Control and Microbiology projects. It may also involve training team members, handling and disposing of biohazard materials, preparing quality-system documentation and microbiological trending reports, and performing other related duties as required. The role is based in Lexington and works a second shift, Sunday through Thursday, from 2 p.m. to 10 p.m. or 3 p.m. to 11 p.m.

Requirements

• Bachelor of Science in Microbiology, Biology, Life Sciences, or a related field.
• At least 2 years of practical laboratory experience in a manufacturing environment.
• Experience with general documentation practices and GMP-compliant data-entry forms, with attention to detail.
• Working knowledge and practical experience with good laboratory practices in a microbiology laboratory.
• Competency in microbiology techniques such as Gram staining, isolation plating, media preparation, and microorganism identification methods.
• Experience with common microbiology laboratory instrumentation, especially autoclaves, air samplers, light microscopes, biohazard cabinets, and water purification systems.
• Hands-on experience with basic laboratory equipment such as pH equipment, balances, and water baths, along with other equipment used in microbiology methods.
• Understanding of basic laboratory safety and biohazard and chemical-waste disposal practices.
• Knowledge of cGMPs and pharmaceutical industry expectations.
• Intermediate proficiency in MS Office, including Word, Excel, Access, and Outlook.

Responsibilities

• Develop microbiological test methods and method validations.
• Perform microbiological testing of raw materials, work-in-process, and finished products for product approval and release.
• Prepare protocols, final reports, and test methods related to microbiological method development and validation.
• Perform media growth promotion and maintain bacterial cultures.
• Support the facility in resolving nonconformance issues and identifying corrective and preventive actions related to environmental monitoring excursions.
• Complete environmental monitoring and laboratory-related investigations and document results properly.
• Maintain GMP/GLP documentation relevant to assigned duties and responsibilities.
• Maintain laboratory instrumentation required for testing and keep the laboratory clean according to SOP guidelines.
• Assist in reviewing test data and report deviations to a supervisor.
• Coordinate activities with other departments and external vendors to support facility goals and objectives.
• Assist management with writing and updating SOPs.
• Participate in projects involving the Quality Control and/or Microbiology departments.
• Train team members in microbiology and chemistry laboratories as required.
• Ensure proper handling and disposal of biohazard material in compliance with OSHA requirements and SOPs.
• Compose and assist with quality-system documentation, including failure investigations, CAPA, calibration, and change control.
• Compose microbiological trending reports and protocols.
• Perform other related duties as required.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level