Microbiologist II

Piramal Pharma Ltd • Lexington, KY

7d

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 and validates microbiological test methods, prepares related protocols and reports, and conducts environmental monitoring and investigations. It also supports quality systems, laboratory operations, and collaboration across departments and with external vendors. This position is in the Microbiology (MQC) department at the Lexington location and reports to the Microbiology Manager. The stated schedule is a second shift, Sunday through Thursday, either 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 particular 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, water baths, and other equipment commonly used in microbiology methods.
• Understanding of basic laboratory safety, biohazard practices, and chemical waste disposal.
• Knowledge of cGMPs and pharmaceutical industry expectations.
• Intermediate proficiency with 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 facility efforts to resolve nonconformance issues and identify corrective and preventative actions related to environmental monitoring excursions.
• Complete environmental monitoring and laboratory-related investigations and document results appropriately.
• Maintain GMP/GLP documentation relevant to assigned duties and responsibilities.
• Maintain laboratory instrumentation required for testing and keep the laboratory clean in accordance with SOP guidelines.
• Assist with review of 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 Standard Operating Procedures.
• 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 systems 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