Microbiologist III

Build your future at Curia, where our work has the power to save lives. Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

About the role

The Quality Control Microbiologist III is responsible for performing advanced microbiological testing and quality activities to support product production, environmental monitoring, and product release in a pharmaceutical manufacturing environment. This role ensures compliance with regulatory requirements and company standards by conducting microbiological assays, analyzing trends, and accurately documenting and reporting results. Additionally, the QC Microbiologist III plays a key role in conducting QC risk assessments, identifying potential microbiological risks, and troubleshooting deviations. This position collaborates with cross-functional teams to drive continuous improvement initiatives, maintain product quality, and uphold patient safety.

Responsibilities

• Perform microbiological testing (endotoxin, sterility, and bioburden) for raw materials, in-process materials, intermediates, and final products.
• Conduct microbiological testing (endotoxin, bioburden) for utilities such as water, steam, nitrogen, etc.
• Perform environmental monitoring of cleanrooms in compliance with USP and EU specifications.
• Review, trend, and report results for environmental, personnel, in-process, raw material, finished product, and utilities testing.
• Conduct microbial characterization (gram stain, catalase, oxidase, and coagulase tests) and prepare and send out samples for microbiological identification.
• Maintain historical files for organisms found in classified areas, including microbial identification and trending.
• Perform line clearances and line start verifications, as well as inspections of media fills.
• Serve as the Subject Matter Expert (SME) for microbiological assays such as sterility (including biological indicator testing) and growth promotion testing for all incoming media used in the microbiology laboratory.
• Perform microbial limits/enumeration testing and handle QC microbiological sample receipt, including internal testing, logging, processing, tracking, distribution of test results, and closure.
• Author and revise controlled documents, including Standard Operating Procedures (SOPs), Investigational Protocols, Risk Assessments, and others as needed.
• Initiate Out of Specification (OOS) or Environmental Monitoring Excursion investigations, recommend appropriate Corrective and Preventive Actions (CAPAs), and complete effectiveness checks.
• Oversee equipment cleaning and maintenance, including managing supplies and inventory.
• Act as a liaison with vendors for maintenance, preventive maintenance (PM), and calibration of equipment.
• Ensure general laboratory housekeeping and maintain a clean, organized workspace.
• Facilitate the revision and release of all controlled documents in a timely manner.
• Coordinate mandatory reviews of SOPs and month-end reports, ensuring they are completed on schedule.
• Read/interpret SOPs to ensure compliance.
• Provide guidance and mentorship to team members.
• Foster a collaborative and positive work environment.
• Champion change and promote a safe and healthy work environment by actively identifying and addressing potential hazards.
• Demonstrate strong attention to detail and proficiency in the validation/qualification of lab microbiological techniques.
• Provide oversight for projects to update/maintain official document templates.
• Direct and manage the Change Control System.
• Maintain up-to-date trainings.
• Other duties as assigned.

Requirements

• Bachelor’s degree in a scientific discipline, preferably microbiology or related field.
• Minimum of five (5) years related work experience.
• Minimum of three (3) years industry experience in a GMP or GLP environment, preferred.
• Previous experience with pharmaceutical cleanroom environments, preferred.
• Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485, and 17025, preferred.
• Experienced and proficient in the validation/qualification of lab microbiological techniques, preferred.

Skills

• Ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations.
• Strong written and verbal communication skills, along with effective presentation skills.
• Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages.
• Strong grasp of algebraic and geometric principles.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline daily functions.
• Adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.
• Strong GDP acumen.
• Proficient in using spreadsheets for data entry, basic calculations, and organizing microbiological data.

Other Qualifications

• Must pass a background check.
• Must pass a drug screen.
• May be required to pass Occupational Health Screening.
• Must be able to obtain and maintain gowning certification.
• Must be able to obtain and maintain media qualification.
• Must be able to wear a respirator.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Regular or occasional lifting, pushing, and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently.
• Regular sitting, standing, and reaching, with some roles requiring prolonged periods of time for each activity.
• Visual acuity, both close and distant, along with depth perception is necessary, with or without corrective lenses. Employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents.
• Hand and finger dexterity are integral, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons.
• Occasional stooping, kneeling, twisting, crouching, crawling, and balancing.
• Certain roles may involve climbing and working at elevated heights.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• The employee may be required to work in an office, manufacturing, or warehouse environment.
• The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.
• The pharmaceutical manufacturing environment is sterile, requiring aseptic gowning. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes, and powered air purifying respirators) is necessary, depending upon the task at hand.
• The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.
• The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.
• Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities, and vibration.
• Some positions may work with or be exposed to compressed gases and must wear ear protection.
• All environments may be subject to working with or being exposed to cleaning agents.

Benefits

• Generous benefit options (eligible first day of employment).
• Paid training, vacation, and holidays (vacation accrual begins on first day of employment).
• Career advancement opportunities.
• Education reimbursement.
• 401K program with matching contributions.
• Learning platform.