EmployIndy
  • Immediate Opportunities - Life Sciences
  • indianapolis, IN, USA
  • Full Time
  • Full package of benefits

Microbiology Analyst l - Exelead


EmployIndy has partnered with a privately owned pharmaceutical company located on the NW side of Indianapolis. Our employer partner specializes in rare disease and orphan drugs with an emphasis on complex liposomal and PEGylated formulations and currently seeking candidates for a Microbiologist Analyst I.

Position Overview:
This is an entry level job in the department. The primary purpose of this role is to perform environmental and water monitoring. The analyst will be responsible for routine and production related environmental monitoring and will be required to aseptically gown to enter and collect samples from the aseptic core.

Major Responsibilities:
• Environmental monitoring of the aseptic area during production fills or weekly monitoring
• Must immediately notify supervisor if affected by infectious disease or open lesions on body, as individuals are not permitted to enter manufacturing areas or handle product if these conditions exist.
• Water collection and testing of WFI, Clean Steam, and the Deionized Water
• Performs media fill qualification and release in support of environmental monitoring program.
• Bioburden testing of product and sanitizer samples
• Endotoxin testing of water and in-process samples
• Trending of data in excel and access
• Perform sampling activities in support of environmental investigations
• Maintenance of the cleanliness of the microbiology laboratory area, refrigerators, and incubators
• Handling of wastes including hazardous wastes. Attendance at mandatory annual hazardous waste training meeting(s). Demonstration of competency in training by passing test(s) administered by the company or consultant providing such training.
• Responsible for adhering to the Environmental, Health and Safety program.
• Performs special projects and other duties as assigned.
• As a part of the employee's job requirements, the employee may be required to handle wastes including hazardous wastes. The employee must attend mandatory annual hazardous waste training meeting(s) and show a competency in that training by passing test(s) administered by the company or consultant providing such training.
Scope:
• 70% Environmental monitoring (including review and trending)
• 20% In-process water and product testing
• 10% Execution of selected projects as directed my Microbiology manager

Requirements:
• Bachelor's Degree or equivalent in Microbiology or Biological Sciences.
• Experience with aseptic technique and/or working in aseptic environments.
• Ability to gown aseptically for Manufacturing and Aseptic Filling areas.
• As persons in this role are engaged in sampling and environmental monitoring during open manufacture of medicinal products, individuals must not be affected by an infectious disease nor have open lesions on any exposed surface of the body.
• Working hours will require flexibility with available work hours.
• Knowledge of Microsoft Excel and Word Processing software and sufficient mobility to work in manufacturing processing areas are also required.

Full package of benefits

Exelead

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