Sr. Microbiologist

Piramal Pharma•Lexington, KY

19d

About The Position

The Senior Microbiologist works in the Microbiology Department at Piramal Pharma Solutions in Lexington and reports to the Microbiology Manager. The role provides technical expertise as a subject matter expert for audits, data review, and laboratory expansion projects. It also supports laboratory operations, compliance, process improvements, and growth.

Requirements

B.S. in Microbiology, Biology, Life Sciences, or a related field.
5–7 years of experience in high-throughput microbiology laboratories.
At least 3 years of applied microbiology experience in a commercial pharmaceutical, GMP manufacturing environment; preferably in parenterals and a CMO/CDMO or clinical environment.
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 common to microbiology methods.
Understanding of basic laboratory safety, biohazard practices, and chemical waste disposal.
Experience with general documentation practices and GMP-compliant data entry forms, with attention to detail.
Knowledge of cGMPs and understanding of pharmaceutical industry expectations.
Intermediate proficiency with MS Office, including Word, Excel, Access, and Outlook.

Responsibilities

Prepare, review, and approve SOPs, test methods, protocols, reports, trending reports, data reviews, CCRs, CAPAs, and risk assessments.
Provide cGMP and laboratory training to Microbiology staff, offer technical support and troubleshooting, and train analysts in laboratory practices and standard microbiological procedures.
Lead laboratory investigations and deviations and implement CAPAs.
Provide information about Quality Control systems and data to internal or external regulatory personnel during inspections or inquiries, serving as a subject matter expert as needed.
Support process improvements and expansion growth.
Develop and implement procedural guidelines within the Microbiology laboratory in conjunction with Quality Assurance.
Participate in developing cleaning validation and verification, environmental monitoring and control, utilities and HVAC monitoring, sterility, and microbial enumeration programs and tests.
Monitor applicable information published by the US FDA and pharmaceutical manufacturing and laboratory technology organizations, and review or incorporate current requirements and guidelines into best practices.
Work with Microbiology management to maintain environmental monitoring and testing schedules and assess testing priorities.
Monitor equipment calibration and identify new equipment needs.
Perform other related duties as required.