Microbiologist ; Onsite

Core Hours

Tuesday - Saturday, 8:00 am - 5:00 pm

Training hours may vary.

Ensure product quality as it relates to raw material, components, product, and environmental microbial testing.

• Perform work in a laboratory and clean‑room environment requiring clean‑room gowning, including:
  • Company‑provided scrubs
  • Shoe covers and sterile boot covers
  • Hairnets (and beard covers as applicable)
  • Tyvek coveralls
  • Gloves
  • Full‑face masks/hoods
  • Goggles
  • 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.
• Perform utilities sampling and testing (compressed gas, steam, and water).
• Assist with the set‑up 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; 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 determination of root causes for environmental excursions and lab deviations.
• 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.

• Understanding of CGMPs and GDPs.
• Experience with routine culture/molecular techniques, microbial identification procedures, endotoxin and bacterial plating instruments.
• Strong verbal, written communication skills and computer skills.
• Provide necessary coaching, guidance, and mentorship to specialists and associates to improve job performance.
• Interact with peers and members of other departments in a professional, team‑oriented manner.
• 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.
• Understanding basic math and writing skills to document production activities in batch records and/or logbooks.
• Must keep accurate records and perform mathematical calculations.
• Ability to legibly complete required documentation.
• Strong attention to detail 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.

• Center on People:
  Commit to the well‑being of patients and employees, treating them as valued partners.
• Are Proactive & Agile:
  Embrace change, respond swiftly, and drive extraordinary outcomes.
• Act Ethically:
  Conduct business in an ethical, compliant, and socially aware manner, promoting diversity, equity, inclusion, and sustainability.
• Constantly Improve:
  Collaboratively improve products, systems, processes, and services by reducing waste, increasing efficiency, and enhancing quality.
• Are Accountable:
  Communicate with honesty, transparency, and clarity, taking ownership of work and actions.

• Bachelor’s degree in Microbiology, Biology, or a closely related field required.
• One or more years of laboratory experience, including microbiology within a regulated industry.

• Valid driver's license and acceptable motor vehicle record required.
• May require overtime and occasional holiday work.