Senior Microbiology Specialist – GMP Methods

Piramal Pharma Solutions Inc.; Lexington (KY); On-site; USD 60,000 - 76,000; Full time

Job summary

Piramal Pharma Solutions Inc. in Lexington, KY, is seeking a Microbiologist II to perform microbiological testing of raw materials, in-process, and finished products, ensuring SOP and GMP adherence. Shift: Tue-Sat 2pm–10pm or 3pm–11pm; reports to Microbiology Manager.

Ideal candidates hold a BS in Microbiology or related field with 2+ years in manufacturing labs and strong documentation skills. Proficiency with MS Office and lab instrumentation is required.

Qualifications

• B.S. in Microbiology, Biology, Life Sciences, or related field.
• 2+ years of practical laboratory experience in a manufacturing environment.
• Experience with GMP documentation and data entry with attention to detail.
• Knowledge of microbiology techniques including Gram staining, isolation plating, media prep, and ID methods.
• Experience with common microbiology instrumentation such as autoclaves, air samplers, microscope, biosafety cabinets, and water systems.
• Hands-on experience with basic lab equipment (pH, balances, water baths, etc.).
• Understanding of lab safety, biohazard and chemical waste disposal.
• Knowledge of cGMPs and pharma industry expectations.
• MS Office proficiency (Word, Excel, Access, Outlook).

Responsibilities

• Develop microbiological test methods and validations.
• Perform microbiological testing of raw materials, in-process, and finished products for release.
• Prepare protocols, final reports, and test methods for development and validation.
• Perform growth promotion and maintenance of cultures.
• Support facilities to resolve nonconformances and CAPA actions as related to environmental monitoring.
• Complete environmental monitoring and related investigations; document results.
• Maintain GMP/GLP documentation relevant to duties.
• Maintain laboratory instrumentation and ensure cleanliness per SOPs.
• Assist in review of test data and report deviations to supervisor.
• Coordinate with other departments and external vendors to meet goals.
• Assist management in writing/updating SOPs.
• Participate in projects with QC and/or Microbiology teams.
• Train team members in microbiology and chemistry labs as required.
• Ensure proper handling and disposal of biohazard material per OSHA and SOPs.
• Contribute to quality system documentation (CAPA, investigations, changes control).
• Prepare microbiological trending reports and protocols.
• Perform other related duties as required.

Skills

Microbiology techniques

GMP compliance

Documentation practices

MS Office proficiency

Education

BS in Microbiology/Biology/Life Sciences

Tools

Autoclaves

Air samplers

Light microscope

Biohazard cabinets

Water purification system

Job description

Piramal Pharma Solutions Inc. in Lexington, KY, is seeking a Microbiologist II to perform microbiological testing of raw materials, in-process, and finished products, ensuring SOP and GMP adherence. Shift: Tue-Sat 2pm–10pm or 3pm–11pm; reports to Microbiology Manager.

Ideal candidates hold a BS in Microbiology or related field with 2+ years in manufacturing labs and strong documentation skills. Proficiency with MS Office and lab instrumentation is required.