Environmental Monitoring (EM) Technician

Xseer Pharmaceuticals is hiring an Environmental Monitoring Technician in Los Angeles, CA. The role involves routine environmental monitoring, compliance with cGMP standards, and investigation of deviations. Candidates should have a degree in Microbiology or related field, with experience in environmental monitoring. The position requires proficiency in aseptic techniques and is full-time with a salary of $68,640 - $72,800, along with benefits including health and dental insurance.
Job Summary:
We are seeking an Environmental Monitoring (EM) Technician to join our team Xseer Pharmaceuticals, a 503B compounding facility. The EM Technician will be responsible for performing routine and non-routine environmental monitoring of classified manufacturing areas, ensuring compliance with current Good Manufacturing Practices (cGMP) and regulatory standards. This position involves conducting surface, viable air, non-viable air, and personnel sampling, as well as supporting investigations into deviations and out-of-specification (OOS) results. The ideal candidate will have technical expertise in environmental monitoring within a sterile pharmaceutical manufacturing setting and a thorough understanding of cGMP requirements.

Key Responsibilities:
• Routine Environmental and Personnel Monitoring: Perform and document routine surface, viable air, non-viable air, and personnel sampling, including gown qualifications, in classified areas (ISO 5, 7, and 8) according in compliance with aseptic techniques and environmental control standards.
• Deviation and OOS Investigation: Participate in the investigation of environmental monitoring deviations and OOS results.
• Plate Incubation and Reading: Incubate environmental monitoring plates according to standard procedures and defined incubation conditions. Perform colony counting as needed.
• Documentation and Reporting:
• Maintain accurate and complete records of all environmental monitoring activities. Prepare EM data for periodic trend reports, regulatory submissions, and internal audits. Ensure data integrity and compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).
• Compliance and Training:
• Ensure compliance with cGMP, FDA, and state regulations related to a 503B compounding facilities. Provide training to new staff on environmental monitoring procedures and aseptic techniques. Complete daily room release and Quality Audit activities

Qualifications:
• Bachelor’s degree in Microbiology, Biology, or a related field and 1+ years of experience in environmental monitoring within a pharmaceutical or 503B compounding environment OR High School Diploma and 3+ years of experience.
• Experience with environmental monitoring equipment (e.g., particle counters, microbial air samplers, contact plates).
• Proficiency in aseptic techniques and cleanroom gowning procedures.
• Ability to work in a fast-paced, highly regulated environment with strong attention to detail.

Preferred Skills:
• Experience with non-viable (PMS) and viable (Lighthouse) equipment and software and electronic quality management systems (eQMS).
• Familiarity with microbiological identification techniques.
• Previous experience with media fill trials and cleanroom qualification.

Status: Salary, Exempt.

Job Type: Full-time

Pay: $68,640.00 - $72,800.00 per year

Benefits:
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:
• 8 hour shift

Ability to Commute:
• Los Angeles, CA 90025 (Required)

Ability to Relocate:
• Los Angeles, CA 90025: Relocate before starting work (Required)

Work Location: In person