Microbiologist I

Piramal Pharma Limited; Lexington (VA); On-site; USD 55,000 - 75,000; Full time

Job summary

Pharma Solutions in Lexington, VA is seeking a Microbiologist I to perform routine release testing of raw materials and finished products, while maintaining compliance with laboratory SOPs. The role reports to the Microbiology Manager and involves environmental monitoring, data review, and SOP updates.

Responsibilities include LAL testing, gram staining, and microbiology testing across materials and processes, with emphasis on GMP/GLP practices and proper documentation. Full-time position onsite.

Qualifications

• B.S. in Microbiology, Biology, Life Sciences, or related field.
• Minimum 1 year practical laboratory experience, preferably in a manufacturing environment.
• Knowledge of good laboratory practices (GLP) and GMP/cGMP expectations.
• Experience with microbiology lab instrumentation (autoclaves, air samplers, microscope, biohazard cabinets, water purification).
• Practical skills with basic lab equipment (pH meters, balances, water baths).
• Proficient with MS Office and data entry practices.

Responsibilities

• Perform microbiological testing of raw materials, work-in-process, and finished products for release.
• Perform environmental monitoring of facilities and water systems in accordance with SOPs.
• Maintain environmental monitoring trend data to identify trends and drive improvements.
• Support resolution of nonconformance issues and participate in CAPA activities.
• Complete environmental monitoring and lab investigations with proper documentation.
• Handle LAL testing and other microbiological assays as needed.
• Maintain GMP/GLP documentation and instrument calibration records.
• Train team members in microbiology and related laboratory practices.
• Handle biohazard material following OSHA and SOP guidelines.

Skills

Gram staining

Isolation plating

Media preparation

Microorganism identification

Lab instrumentation

cGMP knowledge

MS Office

Education

Bachelor's degree in Microbiology

Tools

Autoclaves

Air samplers

Light microscope

Biohazard cabinets

Water purification system

Job description

Business: Pharma Solutions

Department: Microbiology (MQC)

Location: Lexington

Job Overview

Reporting to the Microbiology Manager, the primary purpose of the Microbiologist I is to perform routine release testing of raw materials and finished products, while maintaining compliance of laboratory standard operating procedures.

Reporting Structure

This position Reports to the Microbiology Manager.

Key Responsibilities

• Perform microbiological testing of raw materials, work-in-process, and finished product for product approval and release.
• Perform and document environmental monitoring of the facilities and water systems in compliance with Standard Operating Procedures, as needed for cross-functional support.
• Maintain environmental monitoring trend data to drive continuous improvements identify trends and draw conclusions.
• Provide support to facility to resolve nonconformance issues and identify corrective and preventative actions as related to environmental monitoring excursions.
• Complete environmental monitoring and laboratory related investigations and properly document results.
• Perform LAL, water analysis (as needed), growth promotion, gram staining, identification of microorganisms and other microbiological testing
• Perform and document environmental monitoring in compliance with Standard Operating Procedures.
• Maintain GMP/GLP documentation relevant to the duties and responsibilities assigned.
• Maintain laboratory instrumentation required for testing and cleanliness of the laboratory per SOP guidelines.
• Maintain and track assigned testing activities to completion.
• Assist in the review of test data and report any deviations to supervisor.
• Assist management in writing/updating Standard Operating Procedures (SOPs)
• Participate in projects involving the Quality Control and/or Microbiology departments
• Train team members in microbiology and chemistry laboratories
• Handle and dispose of biohazard material in compliance with OSHA and Standard Operating Procedures.
• Perform other related duties as required.

Qualifications

• B.S. in Microbiology, Biology, Life Sciences, or related field
• Must have a minimum 1 year of practical laboratory experience, preferably in a manufacturing environment
• Working knowledge and practical experience with good laboratory practices in a microbiology lab environment and competency with microbiology techniques such as Gram staining, isolation plating, media preparation and microorganism identification methods.
• Experience with common microbiology lab instrumentation is a requirement, especially with autoclaves, air samplers, light microscope, biohazard cabinets and water purification system
• Practical hands on experience with basic lab equipment such as pH, balances, water baths and other equipment common to microbiology methods
• Must understand basic lab safety, bio-hazard and chemical waste disposal practices
• Experience with general documentation practices and GMP compliance with data entry forms with specific attention to details.
• Knowledge of cGMP’s and understand the pharmaceutical industry expectations.
• Intermediate proficiency in MS Office (i.e. MS Word, MS Excel, Access, Outlook)

Full time