Environmental Monitoring Technician

AxogenVandalia, OH
$23 - $28Onsite

About The Position

The Environmental Monitoring (EM) Technician supports Operations and Quality by performing environmental monitoring activities in classified cleanroom environments to ensure compliance with regulatory and quality requirements. This role is critical to maintaining contamination control and supporting the manufacture of biologic products. Responsibilities include the collection of viable and non-viable samples, accurate and compliant documentation, and adherence to Good Manufacturing Practices (GMP) and aseptic techniques. The EM Technician will work an assigned shift aligned to business needs and may be required to support additional shift or weekend coverage as needed to support manufacturing operations.

Requirements

  • Associate’s degree or technical certification in microbiology, biology, chemistry, or a related scientific field required, Bachelor’s degree preferred.
  • Relevant GMP experience may be considered in lieu of degree.
  • 0 years’ experience working in a GMP-regulated environment (pharmaceutical, biologics, or medical device).
  • Knowledge of aseptic technique and contamination control principles.
  • Familiarity with environmental monitoring programs in classified cleanrooms.
  • Experience with EM instrumentation.

Responsibilities

  • Perform viable and non-viable environmental monitoring in classified cleanroom environments under both static and dynamic conditions.
  • Collect air and surface samples in accordance with approved procedures and sampling plans.
  • Execute environmental monitoring in support of routine manufacturing operations and EM protocols.
  • Ensure accurate, timely, and compliant documentation in accordance with Good Documentation Practices (GDP).
  • Properly label, handle, and transfer samples to QC for incubation and analysis.
  • Set up, operate, and maintain EM equipment (e.g., particle counter, viable air samplers).
  • Verify equipment status and ensure materials used are appropriate and within qualification.
  • Perform cleaning of equipment and work areas as required.
  • Communicate sampling status and issues effectively to Quality and Operations personnel.
  • Perform sampling activities aligned to the assigned shift schedule with flexibility to support additional shifts or weekend coverage as needed.
  • Maintain trained qualifications and demonstrate proficiency in EM techniques.
  • Support investigations, protocol execution, and continuous improvement initiatives as needed.
  • Comply with all company policies procedures, and SOPS.
  • Perform other duties as assigned.

Benefits

  • Health
  • Dental
  • Vision
  • Matching 401K
  • Paid Time Off
  • 9 Paid Holidays + 3 Floating Holidays
  • Dependent Care Flexible Spending Accounts
  • Medical Flexible Spending Accounts
  • Tuition Reimbursement
  • Paid Parental Leave
  • Paid Caregiver Leave
  • Basic Life Insurance
  • Supplemental Life Insurance
  • Employee Stock Purchase Plan
  • Disability Insurance
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