Quality Control Microbiologist EM

Job Title: Quality Control Microbiologist - Environmental MonitoringJob Description

This role supports a new commercial cell therapy production center by performing quality control microbiological testing and environmental monitoring for commercial products. You will contribute directly to Phase 3 cell therapy manufacturing in a cutting-edge GMP environment, helping ensure product quality and patient safety for innovative therapies in the autoimmune and oncology space. The position combines hands-on laboratory work, environmental and utility monitoring, and participation in validation and manufacturing activities as the site advances toward BLA and commercial approval.

Responsibilities

• Perform environmental and utility monitoring and sampling as a primary function, including routine and non-routine activities in GMP cleanroom and manufacturing areas.
• Conduct routine and non-routine inspection of media fill samples (AOQ/APV), and perform collection and testing of media, final product, validation-related, and critical utility samples according to approved SOPs.
• Receive, quarantine, and store purchased microbiological media pending laboratory release, ensuring proper documentation and traceability.
• Monitor biohazardous waste and coordinate its removal with qualified safety personnel in accordance with applicable procedures and regulations.
• Participate in validation and commercial/developmental manufacturing activities, including environmental monitoring performance qualification (EMPQ) and related studies.
• Review and issue Environmental Notifications based on raw data and validated electronic data acquisition systems, ensuring accurate interpretation and timely communication of results.
• Represent Quality Control for the area of specialization in site meetings and cross-functional discussions, providing technical input on environmental monitoring and microbiology topics.
• Support testing of solid oral dosage forms, packaging components, raw materials, and sterile products as required by quality control needs.
• Troubleshoot standard instrumentation and test methods, including environmental monitoring equipment and microbiological assays, to resolve issues and maintain data integrity.
• Perform activities in support of final product release testing, including assays for endotoxin, sterility, and particle isolation, as well as raw material testing such as media growth promotion.
• Perform environmental monitoring activities including surface viable air sampling, non-viable air monitoring, and personnel monitoring in classified areas.
• Conduct bioburden testing of water and product, and measure viable and non-viable particles and moisture in compressed gases and air.
• Apply aseptic techniques and general microbiology methods such as gram staining and plate streaking to support routine laboratory testing.
• Use MODAL/LIMS and other electronic systems to document test results, manage samples, and support data integrity and compliance.
• Author and review deviations, SOPs, and other quality documents, contributing to a structured approach to change control and regulatory compliance.
• Participate in training and mentoring activities, helping colleagues understand structured processes, change control, and regulatory expectations (including ICH and FDA regulations).
• Collaborate with cross-functional teams on projects aimed at meeting BLA and commercialization timelines, balancing independent work with team-based assignments.
• Engage in regular team meetings, one-on-one check-ins, and project reviews to ensure tasks are completed on time and in alignment with quality and regulatory requirements.

Essential Skills

• Minimum of 2+ years of relevant experience in quality control microbiology, environmental monitoring, or a related field.
• Associate's degree or Bachelor of Science degree in microbiology, biology, or a related scientific discipline.
• Hands-on experience with environmental monitoring in GMP or cleanroom environments, including air and surface sampling and personnel monitoring.
• Practical microbiology experience, including aseptic technique, gram staining, plate streaking, and handling of bacterial cultures.
• Experience with quality control testing such as sterility testing, endotoxin testing, bioburden testing, and media growth promotion.
• Working knowledge of current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs) applied in a daily laboratory setting.
• Familiarity with compliance documentation and regulations, including USP and other applicable regulatory requirements.
• Ability to troubleshoot standard laboratory instrumentation and test methods used in microbiology and environmental monitoring.
• Proficiency with electronic systems such as MODAL/LIMS or similar laboratory information management systems.
• Proficiency in Microsoft Office applications for data analysis, documentation, and communication.
• Strong verbal, written, and interpersonal communication skills, with the ability to explain compliance expectations and the impact of QC work on product quality.
• Ability to work effectively both independently and as part of a team in a fast-paced, highly regulated environment.

Additional Skills & Qualifications

• Prior experience in the biopharmaceutical or pharmaceutical industry, particularly in QC microbiology or environmental monitoring.
• Previous laboratory experience in a GMP setting, including cleanroom operations and aseptic processing support.
• Experience with environmental monitoring performance qualification (EMPQ) and technical training on facility and utility system monitoring.
• Knowledge of HPLC and UPLC systems and their role in quality control testing.
• Familiarity with ICH and FDA regulations and their application to cell therapy and biologics manufacturing.
• Experience writing deviations, SOPs, and other controlled documents, with a focus on structured change control and continuous improvement.
• Demonstrated ability to train and coach others on compliance, environmental monitoring practices, and the broader impact of their work on product quality and patient safety.
• Comfort working in a rapidly growing organization where responsibilities may expand as the site progresses toward BLA and commercialization.
• Interest in long-term opportunities, including potential transition to full-time roles and participation in building and scaling the QC microbiology and environmental monitoring team.

Work Environment

The role is based in a combination of office space and GMP manufacturing suites within a new commercial cell therapy production center in Frederick, MD. You will work in classified cleanroom environments that require adherence to strict gowning procedures, aseptic techniques, and environmental monitoring protocols. The facility operates under rigorous GMP standards, with a strong focus on environmental monitoring of air, surfaces, water, gases, and utilities to support Phase 3 and commercial cell therapy manufacturing. You will use a range of microbiological testing equipment, environmental monitoring systems, electronic data acquisition tools, and LIMS platforms in your daily work. The environment emphasizes cross-functional collaboration, with regular team meetings, one-on-one check-ins, and project-based work involving QC, manufacturing, and other functions. As the site advances toward BLA and commercial approval, the team is growing, offering opportunities to take on additional responsibilities, contribute to validation activities, and help shape processes and culture in a high-impact, patient-focused setting.

Job Type & Location

This is a Contract position based out of Frederick, MD.

Pay and Benefits

The pay range for this position is $34.00 - $40.00/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 Frederick,MD.

Application Deadline

This position is anticipated to close on Sep 4, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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