Controlled Environment Specialist

20 hours ago

Manchester, New Hampshire, United States Merrimack Manufacturing Full time
Job Overview

Merrimack Manufacturing is seeking a highly skilled Controlled Environment & Sterilization Technician to join our team. This critical role involves maintaining and monitoring cleanrooms, laboratories, and other controlled spaces to ensure they meet safety and quality standards.

Key Responsibilities:
  1. Perform regular checks to ensure proper conditions and activities are maintained in all controlled environments, including:
  • 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.Requirements and Qualifications:
  • 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.

Merrimack Manufacturing is an equal opportunity employer.

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