Microbiologist

Driven by a commitment to research, quality and service, PDI provides innovative products, educational resources, training and support to prevent infection transmission and promote health and wellness. Encompassing 3 areas, our Healthcare, Sani Professional and Contract manufacturing divisions, we develop, manufacture and distribute leading edge products for North America and the world. We have several locations across the US and are looking for new Associates to join our team!

The Microbiologist I conducts routine microbiological testing and analysis for water; bulk pharmaceutical chemicals and drug products; collects samples; prepares standards/controls, media and sample solutions; and maintains appropriate records.

• Collects purified water samples from the various USP Purified Water Loops used to manufacture or test drug products
• Performs microbiological testing on water, bulk pharmaceutical chemicals, drug products and components, finished products
• Perform method suitability testing on finished products using traditional methods according to procedures. Able to document results and report appropriately
• Prepares media used in the microbiological testing of bulk pharmaceutical chemicals, drug products and components
• Analyze and read microbiological test results while ensuring proper data integrity and GLP/GMP principles are followed
• Perform growth promotion testing for purchased and prepared media
• Samples raw materials and/or finished products for microbial testing
• Prepare laboratory investigation reports, excursions and/or non-conformance evaluation
• Collects environmental samples for microbiological analysis
• Conduct aseptic samplings for evaluation of compressed air and cleaning/sanitization processes
• Perform basic identification of microorganisms (Gram stain)
• Maintain the cleanliness and organization of the laboratory
• Prepares samples for shipment to outside contract laboratory for microbiological testing
• Performs related support activities and duties as assigned.

• Follow all Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA) and other regulatory requirements
• Perform laboratory tasks using general microbiological laboratory techniques and procedures
• Follow internal sampling methods and quality control systems
• Perform general mathematics (addition/subtraction/multiplication/division, dilutions, proportions, percentages)
• Utilize and understand computer applications and programs (Word, Excel, Office 365, LIMS)

• Annual Goals and Objectives
• Right first time Metrics
• Training documentation
• Qualification for performing test methods

• Bachelors degree in Biology or related science from an accredited college or university

• Knowledge of microbiological principles, aseptic techniques, and common laboratory practices
• Working understanding of cGMP, GLP, FDA regulatory requirements, and quality control systems in a pharmaceutical or regulated manufacturing environment.
• Familiarity with microbiological test methods such as bioburden testing, microbial limits testing, environmental monitoring, growth promotion, method suitability, and water system testing
• Ability to read, write, and communicate clearly in English
• Ability to read and comprehend standard operating procedures (SOPs), safety guidelines, and Company policies.

• Minimum of 1-2 years of hands‑on microbiology laboratory experience in a pharmaceutical, medical device, or similarly regulated industry, or an equivalent combination of training and experience.
• Experience performing routine microbiological analyses, aqueous sampling, environmental monitoring, and preparing media, reagents, and controls.
• Experience documenting work in compliance with data integrity principles and preparing laboratory records, deviations, or investigation reports.

• Proficient in general microbiological laboratory techniques including aseptic sampling, plate handling, streaking, gram staining, and microorganism enumeration.
• Strong analytical and observational skills, with the ability to accurately read, interpret, and record microbiological…