Job Title: Environmental Monitoring Analyst II

Job Description

Join a global bio-pharmaceutical company specializing in generic sterile injectable manufacturing as an Environmental Monitoring Analyst II. In this role, you will be part of a team responsible for viable and non-viable monitoring of manufacturing areas, including air, water, and surface sampling. Your work will involve logging samples in a proprietary LIMS and adhering to cGMP documentation practices. Additionally, you will process water, product, and commodity samples and perform bioburden testing.

Responsibilities

• Conduct sampling throughout the entire facility, including air, water, and surfaces.
• Provide assistance to supervisors in training and integrating new hires.
• Serve as an interim lead for the supervisor as needed.
• Engage in process improvement initiatives as requested.
• Perform bioburden testing on water and pharmaceutical product samples.
• Test commodities for non-viable or viable particulates.
• Ensure timely sampling to support microbiology labs in their testing processes.

Essential Skills

• Bachelor's degree in Microbiology, Biology, or related life science field with 1+ years of pharmaceutical industry experience in environmental monitoring.
• Alternatively, an Associate's degree or high school diploma with 2-4 years of relevant experience.
• Experience with aseptic gowning and sampling in an aseptic manufacturing environment.
• Familiarity with LIMS and MODA systems.

Additional Skills & Qualifications

• Experience working in a pharmaceutical lab setup.
• Knowledge of cGMP manufacturing and clean room practices.
• Proficiency in aseptic lab processing and bioburden testing.

Work Environment

This position involves working in a pharmaceutical manufacturing environment, with 80% of time spent in manufacturing areas and 20% in the lab. The role operates on a night shift schedule, 2,2,3 rotating from 7pm to 7am. The work requires aseptic gowning in tight spaces, and adherence to clean room practices, including no makeup, fake nails, or jewelry when sampling. Training will follow NEO, with team-specific trainers guiding certification in routine job aspects over several months. The EM team consists of 45-50 people, divided across day and night shifts, with rotations supervised by one of four supervisors in teams of 5-8 analysts.