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Scientist III - Microbiologist, EM Focus, Analytical Sciences Microbiology - FSP

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Parexel

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Location:
United States , Rahway, New Jersey

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

Not provided
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Job Description:

We are looking to fill a microbiologist position (environmental monitoring focus) working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients in Rahway, NJ. This position offers full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship. The role is intended to be a 40-hour-per-week position.

Job Responsibility:

  • ENVIRONMENTAL MONITORING: Proficiency in the pharmaceutical microbiology laboratory workflow for EM collection and testing, reporting and trending
  • Sampling EM rooms, surface and air
  • Collection and testing water samples
  • Weekly water trends- visually to be able to report back to the source area
  • Equipment responsibilities with metrology oversight, automation, etc
  • MODA USE: Responsible for writing annual reports
  • Responsible for writing trend reports
  • Able to clearly interpret adverse vs desirable data
  • Mold investigations and studies
  • PSIM work
  • Biological indicator analysis and certification
  • Disinfection studies where appropriate
  • Critical thinking with data
  • MICROBIOLOGICAL PRODUCT ANALYSIS: Analyze samples and compile meaningful data
  • Perform Investigations and prepare/respond to CAPA
  • Review, revise Test Procedures/Standard Operating Procedures
  • Ad Hoc work
  • Rotational on-call assignments for responding to alarms
  • MICROBIOLOGICAL ACTIVITIES Include (but not limited to): Receive, verify & Log in samples
  • Return templates and shipping paperwork when and where appropriate
  • Prepare and ship materials offsite for ID/testing (when applicable)
  • Stock culture management and quality control of same
  • Biological indicator management
  • Bioburden testing
  • Water sampling
  • Microbiological media management and quality control of same
  • Sterilization activities
  • Research experiments as deemed appropriate by client management
  • Method Validation/Qualification
  • Other microbiological activities
  • CALIBRATIONS: Execute “Before-Use” calibrations prior to performing testing
  • Review calibration data within the ELN
  • Prepare and submit equipment for calibrations (offsite or onsite)
  • Complete calibration/PM paperwork
  • GMP ACTIVITIES: Prepare GMP documentation as requested by management
  • Perform laboratory sanitizations and ensure cleanliness of laboratory workspace
  • Perform equipment sanitizations (incubators / hoods / refrigerators)
  • Purchase supplies (GMP)
  • Prepare and send documents to Records Center
  • INVESTIGATIONS: Initiate, facilitate, and perform Investigations and NOEs (Notice of Event-NOE) for Environmental samples [NOE for Microbiological Environment Event (MEN)]
  • Inform management of non-conforming events
  • AUDITS: Participate in audits (Regulatory, In-house, Corporate)
  • Participate in self-inspections and safety inspections
  • Retrieve data when requested by Microbiology management
  • TRAINING: Complete assigned training when required
  • Ensure training is complete prior to performing tasks

Requirements:

  • Bachelor’s degree required
  • concentration in a scientific or applied discipline strongly preferred
  • A minimum of two years of experience in pharmaceutical microbiology related position required (occasional overtime)
  • Experience in working in a GMP Pharmaceutical environment with specific experience environmental monitoring
  • Proven technical writing skills (SOPs, protocols)
What we offer:
  • full benefits
  • sick time
  • 401K
  • paid holidays
  • paid time off

Additional Information:

Job Posted:
January 04, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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