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Controlled Environment & Sterilization Technician

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Job Description - Controlled Environment & Sterilization Technician

Merrimack Manufacturing is looking for a Controlled Environment & Sterilization Technician.  This position will assist in maintaining and monitoring cleanrooms, laboratories, and other controlled spaces, ensuring they meet safety and quality standards through thorough environmental and utility monitoring. As a Controlled Environment & Sterilization Technician, your role is essential in maintaining the safety and efficiency of controlled spaces, contributing to the overall success of the team.

Key Responsibilities:
  1. Perform regular checks to ensure proper conditions and activities are maintained in all controlled environments. This includes
                    Cabinet Stocking: Ensure cabinets are stocked with necessary supplies.
                    Gowning Room Maintenance: Keep gowning room racks organized and stocked.
                    Reusable Frock Management: Maintain inventory of reusable frocks.
                    Housekeeping Forms: Keep housekeeping logs updated for cleanliness records.
  1. Environmental Monitoring: Facilitate, collect, review, and report data related to environmental conditions including particulate and bioburden sampling.
  2. Utility Monitoring: Monitor compressed air systems to ensure they function correctly.
  3. Media Qualification: Perform Media Qualification on TSA and SDA plates to ensure quality.
  4. Bioburden and Endotoxin Testing: Facilitate and perform product bioburden and bacterial endotoxin testing.
  5. Nonconformance Support: Assist in addressing nonconformance issues and review nonconformance reports.
  6. Equipment Qualifications: Perform qualification of cleanroom measurement equipment to ensure accuracy.
  7. Standard Procedures Review: Redline standard operating procedures to ensure competency through Change Orders.
  8. Monitoring Data: Enter monitoring results into data trending systems.
  9. Sterilization Data: Record data and trend for sterilization processes.
  10. Micro Lab Supplies: Manage and maintain supplies for the microbiology lab.
  11. Audit Support: Assist with dose audits and endotoxin sampling as needed.

Qualifications and Skills:
  • Basic knowledge of cleanroom technology and regulations (e.g., GMP).
  • Experience in a controlled environment
  • Ability to prioritize tasks and work independently.
  • Good problem-solving skills and attention to detail.
  • Effective communication skills for teamwork.
  • A degree in a related field is preferred.
  • Familiarity with data analysis tools is a plus.
  • Willingness to learn and adapt to new technologies.
  • Basic knowledge of laboratory instruments is helpful.

 
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