Microbiologist - Group Leader (2nd Shift)

Job Description

Primary Responsibilities:

• Perform routine viable and non-viable 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 contamination-free sample collection.
• Perform utility sampling/testing (WFI, purified water, clean steam) and support routine water system monitoring.
• Execute microbiology laboratory testing associated with EM samples, including bioburden, microbial identification, and endotoxin testing.
• Trend, analyze, and interpret EM data; escalate atypical or out-of-trend (OOT) results and support investigations.
• Participate in deviation investigations, root cause assessments, and CAPA development related to environmental or microbiological events.

Inventory management.

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.

Support internal and external compliance audit activities.

May need to be flexible with weekday work hours and weekend support as needed.

Ledger Responsibilities:

• Support and monitors the performance of the team of employees.
• May participate in new hire interviews.
• Supports the on-boarding process of new employees.
• Disseminate administrative communications.
• Demonstrate and promote the company's vision.
• Ensure adherence to highest quality and efficiency standards in laboratory operations.
• Ensure coverage and performance for all shifts, and work duties.
• Performs administrative tasks for team member growth and development.
• Adeptly balance technical lab work with leadership responsibilities.
• Foster morale and teamwork.

Qualifications

• 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.
• Previous experience in a leadership role.
• 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 $29-36/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 holiday.

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