Microbiologist I

About the Role

We are seeking a detail-oriented and motivated Microbiologist with experience in water system monitoring, microbiological testing, and environmental monitoring in a GMP-regulated setting. The analyst will be responsible for collecting and testing water and clean steam samples, performing environmental monitoring, and analyzing facility cleaning and in-process samples.

Responsibilities

Water System

• Collection of samples from the facility water and clean steam systems
• Microbiological testing of the facility and/or laboratory water purification system samples
• GMP review of data
• Qualification and Release of Media
• Analytical testing of the facility cleaning samples and Microbial testing of facility In-Process samples
• Initiation and follow-up of exceeded alert and action limits per procedure
• Participation in the preparation of monthly trending reports

Environmental Monitoring

• Performs plate readings for all environmental monitoring samples as necessary
• Performs environmental monitoring, including unmanned Environmental Monitoring in accordance with Sterile Operations schedule

Laboratory Support

• Logs microbiological testing media and reagents and performs growth promotion
• Provides testing support for validation work such as for Validation Maintenance
• Provides support for third-party testing, including preparation of documents and shipment of samples, sample tracking, and documentation archiving using LabWare
• Provides Microbial Identification support, including documentation, subculturing, Gram stains (where applicable), ensuring chain of custody, review of any vendor report, and interfacing with the vendors

Minimum Qualifications

• Bachelor's degree in Biology or Microbiology or Associate's Degree with a minimum of 1 year of Microbiological experience in the Pharmaceutical Industry
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to work flexible hours at times to support business needs
• Experience with Microsoft Office
• Authorization to work in the United States indefinitely without restriction or sponsorship

Ideal Candidate Profile

• Experience in a Quality Control Lab or Sterile Suite
• Familiarity with cGMP's
• Excellent communication (oral and written)
• Strong Attention to Detail
• A client-focused mindset and a commitment to exceptional service

Schedule

The position is onsite, full-time, Monday-Friday from 7 am-3 pm. Candidates living within a commutable distance of King of Prussia, Pennsylvania, and the surrounding areas are encouraged to apply.

Benefits

• Comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holiday