Scientist III - Pharmaceutical Microbiologist, EM Focus - FSP

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.

Qualifications

• 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)

Required Skills and Experience

• Solid microbiology foundation with experience with proficiency in environmental monitoring
• Proven technical writing skills (SOPs, protocols)

Desired Skills and Experience

• Experience in the pharmaceutical/biotechnology industries preferred

Responsibilities

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

The role requires working more than 40 hours per week (an average of 16 hours per month). This requirement is factored into the compensation.

This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy. Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

About Parexel

Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies.

For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement.

Come join us!