Environmental Monitoring Analyst I

Environmental Monitoring AnalystBuild your future at Curia, where our work has the power to save livesCuria 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.We proudly offerGenerous 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 And more!Summary:The Environmental Monitoring (EM) Analyst conducts microbiological tasks to aid production, such as monitoring cleanrooms for microorganisms and particles. They manage personnel sampling and certification in a cleanroom environment and perform non-routine sample collection for Standard Operating Procedures (SOPs) or investigations.Essential Duties and Responsibilities:Perform environmental monitoring of the 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 Perform 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 Other duties as assignedEducation and Experience:High school diploma or general education degree (GED) Minimum of two (2) years of experience in an Analyst position, preferred Two (2) years related experience in production, manufacturing, and/or cleanroom, preferredComputer Skills:Skilled in Microsoft Word, Excel and Outlook. Ability to quickly adapt and learn new manufacturing software systems.Other Skills and Abilities: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 skillsOther 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 respiratorPhysical 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. 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. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position's physical requirements. 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.The working environments will vary for each Curia position. 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.