Sr. Microbiologist

Piramal Pharma Ltd•Lexington, KY

21d

About The Position

The Senior Microbiologist in the Microbiology department at Piramal Pharma Solutions’ Lexington location provides technical expertise as a subject matter expert for audits, data review, and laboratory expansion projects. The role reports to the Microbiology Manager and supports laboratory operations, compliance, staff training, investigations, and process improvements in a pharmaceutical manufacturing environment. The position prepares and reviews controlled documentation and data, supports regulatory inspections and inquiries, and helps develop and implement microbiology laboratory procedures in conjunction with Quality Assurance. It also contributes to cleaning validation and verification, environmental monitoring and control, utilities and HVAC monitoring, sterility and microbial enumeration testing, equipment calibration, and assessment of laboratory equipment needs.

Requirements

Bachelor of Science in Microbiology, Biology, Life Sciences, or a related field.
5–7 years of experience in high-throughput microbiology laboratories, including at least 3 years of applied microbiology experience in a commercial pharmaceutical GMP manufacturing 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, and water baths, and other equipment common to microbiology methods.
Understanding of basic laboratory safety, biohazard, and chemical waste disposal practices.
Experience with general documentation practices and GMP-compliant data entry forms, with attention to detail.
Knowledge of cGMPs and pharmaceutical industry expectations.
Intermediate proficiency in MS Office, including Word, Excel, Access, and Outlook.

Nice To Haves

Experience in a commercial pharmaceutical GMP manufacturing environment involving parenterals, preferably in a CMO, CDMO, or clinical environment.

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, technical support, troubleshooting, and training in laboratory practices and standard microbiological procedures.
Lead laboratory investigations and deviations and implement CAPAs; write and review SOPs.
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 development of cleaning validation and verification, environmental monitoring and control, utilities and HVAC monitoring, sterility testing, and microbial enumeration 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.