Microbiologist II (2nd Shift)

Tolmar•Windsor, CO

12d•$34 - $35•Onsite

About The Position

This position ensures product quality by performing microbial testing on raw materials, components, products, and the environment. The role involves working in a laboratory and cleanroom setting, requiring specific gowning procedures. The Microbiologist II will perform routine quality control testing under GMP and ISO conditions, including sterility testing, and assist with environmental monitoring, aseptic gowning qualifications, and process simulations. Responsibilities also include utility sampling and testing, laboratory setup, media preparation, organism enumeration, stock culture maintenance, and detailed record-keeping according to GMP guidelines. The role involves writing and executing test methods, test method transfers, instrument validations, and providing data support for environmental monitoring. Additionally, the position assists with utility and facility qualifications, investigations into excursions and deviations, trend reporting, data analysis, and training other department members on specific processes and techniques. The role requires operating under minimal supervision and performing other related duties as assigned.

Requirements

Understanding of CGMP’s and GDP’s
Some knowledge of government regulations of drugs and medical devices as they apply to laboratory work.
Strong verbal, written communication skills and computer skills are required.
Provide necessary coaching, guidance, and mentorship to specialists and associates related to improvements of job performance.
Interact with peers and members of other departments in team settings in a professional manner.
Must be goal-oriented, quality-conscientious, and customer-focused.
Knowledge of laboratory science principles, microbiology lab equipment and microbiology concepts.
Ability to read, understand, and follow work instructions and laboratory test methods.
Ability to work independently and cooperatively on a team.
Effective troubleshooting and problem-solving skills.
Ability to stand for extended periods of time (up to 8 hours or more).
Understanding of basic computer software.
Ability to maintain focus on detail-oriented, repetitive tasks.
Ability to follow and understand written production records and validation protocols.
Ability to work within multi-functional project teams and independently with minimum supervision.
Ability to manage multiple projects simultaneously.
Understanding basic math and writing skills to document production activities in batch records and/or logbooks.
Must be able to keep accurate records and able to perform mathematical calculations.
Ability to legibly complete required documentation.
Strong attention to detail required for documentation in production documents.
Capability to operate on a fast-paced manual process using environmental monitoring equipment.
Maintain and train others on Aseptic technique and work in an aseptic environment.
Bachelor’s degree in Microbiology, Biology or closely related field required
2 or more years of laboratory experience including Microbiology within a regulated industry.
Valid driver’s license and acceptable motor vehicle record required.

Nice To Haves

Experience with routine culture/molecular techniques, microbial identification procedures, endotoxin and bacterial plating instruments preferred.

Responsibilities

Perform job in a laboratory and clean room environment requiring clean room gowning, including company-provided scrubs, shoe covers, sterile boot covers, hairnets (and beard covers as applicable), Tyvek coveralls, gloves, full-face masks/hoods, goggles, and chemical protection PPE.
Assist in performing environmental monitoring in the general and aseptic manufacturing environment.
Assist in performing aseptic gowning qualifications and participate in aseptic process simulations.
Perform routine quality control product testing on pharmaceutical items under GMP and ISO conditions, including sterility testing in an isolator.
Perform utilities sampling and testing (compressed gas, steam, and water).
Assist with the setup of the laboratory and management of daily lab operations (prepare media and solutions).
Incubate and enumerate organisms on cultured media.
Maintain stock cultures of bacteria and fungi.
Maintain notebooks according to GMP guidelines. Preparation of reports and summaries.
Write and execute test methods and work instructions.
Execute test method transfers and instrument validations.
Provide EM data support including entry, review and tracking of EM data.
Assist with utility and facility qualifications.
Assist with investigations (Excursions, CAPA) to aid in the determination of root causes for environmental excursions and lab deviations within and outside of the lab.
Assist with trend reporting and data analysis.
Assist with training other members of the microbiology department and aseptic operations on MODA and viable sampling processes and techniques.
Operate under minimal supervision.
May perform other related duties as required and/or assigned.