Environmental Monitoring Analyst I

About the role

The Environmental Monitoring (EM) Analyst at Curia is responsible for conducting microbiological tasks to support production, including monitoring cleanrooms for microorganisms and particles, managing personnel sampling, and performing non-routine sample collection.

Responsibilities

• Perform environmental monitoring of cleanrooms under USP and EU specifications, both viable and non-viable monitoring.
• Daily preparation of paperwork, supplies, and equipment for EM testing in a cleanroom setting.
• Microbial plating of personnel during manufacturing and personnel qualification.
• Collect data from the particulate monitoring system and audit system to ensure appropriate sensors are activated.
• Resolve environmental equipment malfunctions or errors.
• Perform non-routine or infrequent sampling (e.g., semi-annual static particulate monitoring, quarterly compressed air monitoring).
• Perform current Good Manufacturing Practice (cGMP) documentation and review sampling worksheets for documentation errors.
• Maintain current training status on equipment, procedures, and test methods.
• Read/interpret SOPs to ensure compliance.
• Maintain up-to-date trainings.

Requirements

• High school diploma or GED.
• Minimum of two (2) years of experience in an Analyst position, preferred.
• Two (2) years related experience in production, manufacturing, and/or cleanroom, preferred.

Qualifications

• Skilled in Microsoft Word, Excel and Outlook.
• Ability to quickly adapt and learn new manufacturing software systems.
• Fosters a collaborative and positive work environment.
• Champions change.
• Promotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.
• Demonstrates strong attention to detail.
• Strong writing skills.

Skills

• 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

• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• The essential physical demands will vary for each Curia position.
• All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently.
• Additionally, all positions entail 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 in each role, with or without corrective lenses.
• 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.
• Certain roles may involve climbing and working at elevated heights as well.
• Work Environment
• The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job.
• 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. Therefore, aseptic gowning is required.
• 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.
• In addition, 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.