Cleanroom Specialist

Job OverviewMerrimack Manufacturing is seeking a Cleanroom Specialist to maintain and monitor cleanrooms, laboratories, and other controlled spaces. This role ensures they meet safety and quality standards through thorough environmental and utility monitoring.

About the Role

1. The successful candidate will assist in maintaining proper conditions and activities in all controlled environments.

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.

Requirements and Qualifications

• Bachelor's degree in a related field or equivalent experience.
• 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.
• Familiarity with data analysis tools is a plus.
• Willingness to learn and adapt to new technologies.
• Basic knowledge of laboratory instruments is helpful.

$55,000 - $65,000 per year

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