Microbiologist

Microbiologist

The Microbiologist supports a large, GMP-regulated sterile injectables manufacturing facility by performing environmental monitoring of controlled areas, documenting and analyzing microbiological data, and ensuring compliance with cGMPs and regulatory standards. This role plays a key part in building and expanding new manufacturing capabilities, contributing to process simulations, investigations, and the overall growth of a rapidly scaling campus.

Responsibilities

• Perform environmental monitoring of controlled areas in accordance with established procedures and regulatory requirements.
• Document environmental monitoring testing in the EM database prior to incubation, ensure samples are correctly incubated, and record sample results following incubation.
• Compile and analyze trending data for environmental monitoring tests to support investigations and continuous improvement activities.
• Audit personnel aseptic technique in controlled areas, including during process simulations such as media fills, and provide feedback to support compliance and best practices.
• Author clear and detailed laboratory event and investigation reports that support root cause analysis and corrective actions.
• Communicate issues and findings effectively between departments to ensure timely resolution and alignment with quality standards.
• Collaborate with coworkers to ensure all required tasks are completed accurately and on schedule.
• Document test data clearly and accurately, maintaining data integrity at all times.
• Ensure strict compliance with company policies, procedures, cGMPs, and applicable regulatory requirements in all laboratory and controlled area activities.
• Support the implementation and qualification of new filling and compounding suites and manufacturing lines as the facility expands.
• Contribute to building and strengthening the microbiology and quality culture within a growing team and campus.

Essential Skills

• Bachelors degree (BS/BA) in Microbiology or Biology.
• Completed microbiology coursework and laboratory work that includes the use of aseptic technique.
• Ability to pass and maintain Class 100 / ISO 5 / Grade A gowning qualification for work in controlled environments.
• Capability to lift up to 20 pounds as required by laboratory and facility operations.
• Strong attention to detail and accuracy in documenting test data and maintaining data integrity.
• Ability to work in compliance with cGMPs and regulatory requirements in a pharmaceutical manufacturing setting.
• Effective written communication skills for authoring laboratory event and investigation reports.
• Effective verbal communication skills for collaborating with coworkers and communicating issues across departments.

Additional Skills & Qualifications

• Pharmaceutical industry experience, particularly in sterile injectables or GMP-regulated environments.
• Experience performing environmental monitoring in controlled areas.
• Familiarity with EM databases or similar laboratory information management systems.
• Experience auditing aseptic technique and supporting media fills or other process simulations.
• Interest in contributing to a rapidly expanding manufacturing campus and growing team.
• Ability to adapt to change in a dynamic environment undergoing construction, expansion, and the addition of new manufacturing lines.

Work Environment

This role is based in a very large GMP-regulated manufacturing facility that is undergoing significant expansion and modernization. The campus consists of multiple buildings and is in the process of adding new filling and compounding suites, as well as new manufacturing lines, including an IV bag line expected to go commercial. The site is currently focused on building capacity and infrastructure with a multiyear plan to complete the campus and reach full production of a range of generic medicines, including vitamins, antibiotics, hormones, and other injectable and oral drugs. The team is growing rapidly, with plans to expand from several dozen employees to a much larger workforce over the next few years, offering opportunities to help shape processes, build teams, and support increased production. Work is performed in controlled environments that require Class 100 / ISO 5 / Grade A gowning qualifications and strict adherence to cGMP standards. Employees can expect a professional, highly regulated setting with a strong focus on quality, safety, and collaboration as the facility transitions from construction and expansion to full manufacturing operations.

Job Type & Location

This is a Contract to Hire position based out of Bedford, OH.

Pay and Benefits

The pay range for this position is $26.00 - $26.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully onsite position in Bedford, OH.

Application Deadline

This position is anticipated to close on Oct 9, 2026.