Microbiologist

The position is responsible for performing microbiological analyses, in process bioburden testing, final product endotoxin and sterility testing.

• Completely, accurately, and precisely prepares all laboratory reports and/or test scripts and documents in accordance with cGDP and cGMP requirements
• Demonstrates high ethical standards
• Maintain current training status on relevant equipment and procedures
• Comply with all cGMP, regulatory and corporate and EHS requirements
• Demonstrates ability to multi-task and prioritize work
• Maintain laboratory in audit readiness per cGDP and cGMP practices
• Perform peer review for testing and calculations, as necessary
• Recognizes Out of Specification, atypical and/or anomalous data, escalates to management, as necessary

• Maintain, clean, and sterilize laboratory instruments and equipment
• Perform water sampling, including DI water, WFI and steam
• Perform sterility, endotoxin, bioburden testing of product and microbiological samples
• Subculture and characterize microbial isolates using Gram stain
• Perform growth promotion testing of liquid and plated media, including media fills
• Perform bacteriostasis/fungi stasis testing to validate test methods
• Process and incubate exposed biological indicators
• Receive and prepare samples and equipment for testing
• Incubate and examine tests, including but not limited to bioburden, sterility, BIs and media fill units
• Enumerate bacteria; prepare shipments for outside laboratories
• Understand the science behind the above listed testing requirements, be able to clearly communicate testing requirements and expectations.
• Understand environmental monitoring, the different testing requirements, and the interpretation of the results.
• Operate and maintain laboratory equipment, including but not limited to incubators, autoclaves, ovens, vacuum pumps; assist with qualifications and validations
• Support R&D and Technical Services activities
• Maintain effectiveness of the Quality System components relevant to this position.
• Identify, evaluate, and manage risk to ensure product quality. Communicate risk policies and processes throughout the organization.
• Other duties as assigned.

• B.S in Microbiology, Biological Sciences, or equivalent

• Experience in a lab setting (academic, intern or other)

• Demonstrated intermediate mathematical ability
• High level of attention to detail, well organized and multi-task oriented
• Strong communication skills both written and oral
• Strong problem solving and analytical skills
• Works well in a team environment with a variety of individuals and personalities within and between departments
• Must be able to multitask, be proactive and willing to take initiative and responsibility
• Should be familiar with cGMP and safe work practices
• Make sound judgments. Act ethically
• Demonstrated ability to read, write, and speak clear English.

• Ability to stand for up to 8 hours per day
• Visual Acuity (20/30 corrected vision)
• May be exposed to inclement weather or be required to work in environments or under conditions that require the use of protective gear and/or awareness of personal safety and safety of others
• Frequent sitting, standing, walking, climbing ladders/steps, reading of written documents and use of computer monitor screen, reaching with hands and arms, twisting, writing, talking, bending, handling, turning, balancing, carrying, grasping, listening
• Occasional walking up inclines and uneven terrain, stooping, kneeling, crouching
• Frequent lifting and/or moving up to 20 pounds and occasional lifting and/or moving up to 30 pounds