Microbiologist (2nd Shift)

In your role as Scientist you will be a critical part of the Analytical Research and Development Microbiology team with responsibilities including leading the rapidly growing pipeline via collaboration with stakeholders to deliver on critical data in a good manufacturing practices (GMP) microbiology laboratory including finished products testing utilities and environmental monitoring.

Primary Responsibilities

• Perform routine viable and nonviable Environmental Monitoring of classified cleanroom areas (Grad A-D) including surfaces air and equipment.
• Conduct active air passive air (settle plates) surface sampling in accordance with site EM programs and GMP requirements.
• Operate and maintain EM instruments (e.g. viable air samplers particle counters RODAC plates isolator/BSC environmental sampling tools).
• Execute aseptic sampling techniques to ensure data integrity and contaminationfree sample collection.
• Perform utility sampling/testing (WFI purified water clean steam) and support routine water system monitoring.
• Perform microbiology laboratory testing associated with EM samples including bioburden microbial identification and endotoxin testing.
• Trend analyze and interpret EM data; escalate atypical or outoftrend (OOT) results and support investigations.
• Participate in deviation investigations root cause assessments and CAPA development related to environmental or microbiological events.
• Maintain accurate documentation of sampling activities in compliance with ALCOA and dataintegrity principles. Inventory management.
• Conduct microbiology finished goods testing and biological indicator (BIs) testing
• Support of sterile operations within the quality control department including utilizing isolator for  sterility testing conduct method suitability testing endotoxin microbial enumeration media / reagent quality control testing Experience with testing in clean room environments preferred
• Conduct the execution procedure results and conclusions of experiments in a detailed and organized manner following ALCOA and data integrity principles
• Partner with internal stakeholders and partners including Quality Pipeline and Operations.
• Perform second scientist review microbiology experiments in line with GMP expectations
• Support internal and external compliance audit activities.
• May need to be flexible with weekday work hours and weekend support as needed

Qualifications :

Minimum Requirements:

• Minimum 2 years of pharmaceutical industry experience for applicants with a MS degree or  3 years of experiences for BS degree in Microbiology or related Biological Sciences or equivalent with direct microbiological testing GMP experience
• A proven record of microbiology laboratory experience.
• Excellent written and oral communication skills as well as interpersonal skills are necessary to qualify for this role.
• Knowledge and experience of microbiology testing in context of environmental monitoring aseptic manufacturing and utilities testing in a GMP environment
• Knowledge of current microbiology industry guidelines and compendia
• Authorization to work in the United States indefinitely without restrictions

Preferred Experience

• * Knowledge in sterile nonsterile and aseptic manufacturing and associated GMP product testing
• * Experience in supporting quality investigations in the microbiology discipline
• * Experience with MODA SAP Veeva LIMS is a plus

Additional Information :

Position is full-time Mon-Fri 3pm-11pm Candidates currently living within a commutable distance of Rahway NJ are encouraged to apply. Base compensation is between $27-34/hr based on experience. 2nd shift has a 10% shift differential.  

• Excellent full time benefits including comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time