Controlled Environment & Sterilization Technician
Manchester, NH
Full Time
Quality
Experienced
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:
Qualifications and Skills:
Key Responsibilities:
- 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.
- Environmental Monitoring: Facilitate, collect, review, and report data related to environmental conditions including particulate and bioburden sampling.
- Utility Monitoring: Monitor compressed air systems to ensure they function correctly.
- Media Qualification: Perform Media Qualification on TSA and SDA plates to ensure quality.
- Bioburden and Endotoxin Testing: Facilitate and perform product bioburden and bacterial endotoxin testing.
- Nonconformance Support: Assist in addressing nonconformance issues and review nonconformance reports.
- Equipment Qualifications: Perform qualification of cleanroom measurement equipment to ensure accuracy.
- Standard Procedures Review: Redline standard operating procedures to ensure competency through Change Orders.
- Monitoring Data: Enter monitoring results into data trending systems.
- Sterilization Data: Record data and trend for sterilization processes.
- Micro Lab Supplies: Manage and maintain supplies for the microbiology lab.
- 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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