Scientist III Microbiologist - FSP

We are looking to fill a microbiologist position working as a full-time employee of Parexel FSP on long-term assignment onsite at one of our clients in West Point, PA.

About the role

Parexel FSP provides pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. This role is a 40-hour-per-week position offering full benefits, sick time, 401K, paid holidays, and paid time off. This position does not offer sponsorship.

Responsibilities

• Microbiological Product Analysis
  • Analyze samples and compile meaningful data
  • Perform investigations and prepare/respond to CAPA (Corrective and Preventative Action)
  • Review, revise Test Procedures / Standard Operating Procedures
  • Ad hoc work
  • Rotational on-call assignments
• Microbiological Activities (include but not limited to)
  • Receive, verify & log in samples
  • MLT (Microbial Limits Testing)
  • Method Suitability testing
  • Endotoxin testing
  • Return templates and shipping paperwork when and where appropriate
  • Compile and trend data
  • Prepare and ship materials offsite for ID/testing (when applicable)
  • Environmental monitoring
  • Stock culture management and quality control
  • Biological indicator management
  • Bioburden testing
  • Water sampling
  • Microbiological media management and quality control
  • Sterilization activities
  • Research experiments as deemed appropriate by client management
  • Method Validation/Qualification
  • Other microbiological activities
  • Rotational on-call assignments for responding to alarms
• Calibrations
  • Execute “Before-Use” calibrations prior to performing testing
  • Review calibration data within the ELN (Electronic Laboratory Notebook)
  • Prepare and submit equipment for calibrations (offsite or onsite)
  • Complete calibration/PM paperwork
  • PROCAL entries
• 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) 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
• 3-5 years of experience in a pharmaceutical microbiology related position required; or a MS with 1-2 years of experience

Skills

• Required
  • Solid microbiology foundation with experience in performing product testing
  • Proven technical writing skills (SOPs, protocols)
• Desired
  • Experience in the pharmaceutical/biotechnology industries preferred
  • Experience with environmental monitoring and water testing preferred

Benefits

• Full benefits
• Sick time
• 401K
• Paid holidays
• Paid time off

Schedule

40 hours per week