QC Environmental Monitoring Technician

Department: Quality Control

The QC Environmental Monitoring Technician is responsible for supporting parenteral manufacturing operations through routine environmental monitoring of classified manufacturing areas, as well as conducting clean utility sampling and analysis within both manufacturing and QC laboratory facilities. This role plays a critical part in ensuring compliance with cGMP requirements and maintaining a controlled manufacturing environment to support the production of safe and effective pharmaceutical products.

• Adhere to and promote compliance with all cGMP procedures, Quality Systems, and Good Documentation Practices (GDP).
• Perform routine environmental monitoring of classified manufacturing areas to support both standard operations and Environmental Monitoring Performance Qualification (EMPQ) activities.
• Conduct clean utility sampling and analysis, including but not limited to:
  • Compressed air
  • Potable water
  • Purified water
  • Clean steam
• Support manufacturing and laboratory activities by providing timely and accurate environmental monitoring data.
• Enumerate, review, and document sampling results in LIMS or other laboratory data systems.
• Perform Second Person Verification (SPV) of environmental monitoring results on a routine basis.
• Participate in continuous improvement projects and quality initiatives.
• Assist with authoring and updating Standard Operating Procedures (SOPs) and Work Instructions as required.
• Adhere to and promote compliance with all site safety standards.

• Strong understanding of cGMP requirements and regulatory compliance.
• Experience performing environmental monitoring within filling isolators or restricted access barrier systems (RABS).
• Ability to train and mentor junior Environmental Monitoring Technicians.
• Strong verbal and written communication skills.
• Ability to work effectively with cross-functional teams.

• Ability to work in laboratory and cleanroom environments while wearing appropriate PPE.
• Ability to gown into facility-dedicated cleanroom attire as required.
• Ability to stand or walk for extended periods and perform repetitive tasks.
• Ability to lift, push, pull, and carry up to 30 pounds.

• Ability to work 12-hour shifts.
• Flexibility to work day or night shifts as required, especially during training and startup phases.
• Role may initially support project/startup activities and transition into a routine operational support role.