Qureos Mentor

Poly-Med, Inc.

Description for EM Specialist:The Environmental Monitoring Specialist is responsible for executing and maintaining a comprehensive environmental monitoring program within an ISO 8 cleanroom and associated controlled environments. This role supports manufacturing, quality assurance, and validation activities by ensuring that facilities maintain compliance with internal procedures, regulatory expectations, and industry best practices.Responsibilities for EM Specialist:<ul><li>Perform routine particle, surface, and air sampling in ISO 8 and other classified cleanroom environments.</li><li>Conduct cleanroom occupancy verification and support room classification assessments.</li><li>Execute and document cleanroom certification activities, including airflow, pressure differentials, and recovery testing.</li><li>Calculate, interpret, and document smoke studies, leak tests, and particle count data, ensuring results meet required specifications.</li><li>Write risk assessments, investigations, and mitigation strategies related to environmental excursions, contamination events, and procedural gaps.</li><li>Coordinate and support breach SOP workflows, including response, documentation, impact assessments, and escalation.</li><li>Maintain accurate and timely EM records in accordance with GMP, ISO standards, and internal quality systems.</li><li>Participate in audits, inspections, and CAPA development as needed.</li><li>Collaborate cross-functionally with Manufacturing, Quality, Facilities, and Validation teams to ensure environmental control and continuous improvement.</li></ul>Required Knowledge, Skills and Abilities for EM Specialist:<ul><li>3&ndash;5 years of hands-on environmental monitoring experience in an ISO-classified cleanroom (ISO 8 required; ISO 7/ISO 5 experience a plus).</li><li>Strong understanding of GMP, cleanroom behavior, contamination control, and aseptic techniques.</li><li>Proficiency with environmental monitoring instrumentation, including particle counters, viable air samplers, surface sampling tools, and related equipment.</li><li>Demonstrated ability to perform and interpret airflow visualization (smoke) studies and environmental data trending.</li><li>Excellent written skills for drafting risk assessments, reports, and investigations.</li><li>Strong attention to detail, time management, and ability to work independently or in a cross-functional team.</li></ul>Education/Experience Requirements<ul><li>Bachelor&rsquo;s degree in Microbiology, Biology, or a related scientific field (or equivalent experience)</li></ul>Preferred Qualifications<ul><li>Experience in medical device, pharmaceutical, or biotechnology manufacturing.</li><li>Familiarity with ISO 14644, ISO 13485, and FDA QSR expectations.</li><li>Knowledge of contamination control strategy (CCS) principles.</li></ul>Working Conditions at Poly-Med, Inc.At Poly-Med, Inc., the safety and health of every employee are of the utmost importance. The use of personal protective equipment such as safety glasses, hearing protection devices (ear plugs or earmuffs), and gloves may be required in various working areas.Physical Requirements:Employees are regularly required to talk and hear and are frequently required to sit and/or stand for extended periods of time. Employees are frequently required to walk with occasional requirements to climb stairs; use of hands for gross manipulation, reach with hands and arms; and stoop, kneel, and/or crouch. Lifting as required with proper lifting techniques up to 50 pounds on occasion. Specific vision abilities required by this job include close vision and ability to adjust focus.Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.Job Type: Full-timePay: $51,000.00 - $88,000.00 per yearBenefits:<ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Employee assistance program</li><li>Employee discount</li><li>Health insurance</li><li>Health savings account</li><li>Life insurance</li><li>Paid time off</li><li>Professional development assistance</li><li>Referral program</li><li>Retirement plan</li><li>Tuition reimbursement</li><li>Vision insurance</li></ul>Education:<ul><li>Bachelor's (Required)</li></ul>Experience:<ul><li>CAPA : 1 year (Required)</li><li>Cleanroom: 3 years (Required)</li><li>Particle Count: 3 years (Required)</li><li>Environmental risk assessment: 3 years (Required)</li></ul>Work Location: In person

Environmental Monitoring Specialist

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Poly-Med, Inc.

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Environmental Monitoring Specialist