Microbiologist

Eurofins; Rahway (NJ); On-site; USD 77,366,016 - 97,423,872; Full time

Benefits offered by this job

Medical, dental & vision

401(k) with company match

Paid vacation & holidays

Life and disability insurance

Job summary

Eurofins is seeking a Scientist for its GMP microbiology and environmental monitoring program in Rahway, NJ. You will lead EM activities, perform sampling and testing, and support sterile operations and data integrity in a fast-paced QC environment.

The role requires 2+ years of pharma microbiology GMP experience (MS) or 3+ years (BS), strong communication, and collaboration with QA and Operations. Competitive benefits and schedule.

Qualifications

• 2+ years of pharma microbiology GMP testing for MS holders.
• 3+ years of GMP microbiology testing for BS degree.
• Experience with environmental monitoring, aseptic manufacturing, and utilities testing.
• Excellent written and oral communication skills; interpersonal skills.

Responsibilities

• Lead environmental monitoring in GMP labs.
• Perform EM sampling and analysis per SOPs.
• Operate EM instruments and conduct BI testing.
• Support sterile operations and ALCOA data integrity.
• Assist audits, investigations and CAPA activities.
• Collaborate with QA, Operations and Pipeline.

Skills

GMP microbiology

Environmental monitoring

Aseptic technique

Data integrity (ALCOA)

Communication skills

Education

MS in Microbiology or related

BS in Microbiology or related

Tools

MODA

SAP

Veeva

LIMS

Job description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

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 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.
• Perform microbiology laboratory testing associated with EM samples, including bioburden, microbial identification, and endotoxin testing.
• Trend, analyze, and interpret EM data; upscale 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.
• Maintain accurate documentation of sampling activities in compliance with ALCOA and data‑integrity principles. Inventory management.
• Conduct microbiology finished goods testing and biological indicator (BIs) testing.
• Support of sterile operations within the quality control department includingutilizing 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.

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.

Position is full-time, Mon-Fri 8am-5pm. Candidates currently living within a commutable distance of Rahway, NJ are encouraged to apply. Compensation is between $27-34/hr based on experience.

• 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.