Environmental Monitoring Technician
Job Description
Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one!
Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status.
Why you’ll love working at Axogen:
- Friendly, open, and fun team culture that values unique perspectives
- Company-wide dedication to profoundly impacting patients’ lives
- Comprehensive, high-quality benefits package effective on date of hire
- Educational assistance available for all employees
- Matching 401(k) retirement plan
- Paid holidays, including floating holidays, to be used at your discretion
- Employee Stock Purchase Plan
- Referral incentive program
Axogen Mission and Business Purpose
Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.
Job Summary of the Environmental Monitoring Technician
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 of the Environmental Monitoring Technician
- 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 of the Environmental Monitoring Technician
The specific duties of the Environmental Monitoring Technician include but are not limited to:
- 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.
Location
913 Industrial Drive Place, Vandalia, OH 45377
Benefits/Compensation
Benefits offered for this position include 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, and Disability Insurance, as described in more detail in summary plan descriptions.
Axogen follows healthcare system guidelines with respect to credentialing, vaccinations and other employment/compliance related requirements, as well as CDC guidance. Axogen reserves the right to amend its policies from time to time in its sole discretion.