Technician I - Microbiology

Eurofins US Network; Crown Point (IN); On-site; USD 48,000 - 62,000; Full time

Benefits offered by this job

Excellent health benefits

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA BioPharma Services in Crown Point, IN is hiring a full-time microbiology professional to execute aseptic and sterility testing on medical devices and pharmaceuticals in a cGMP environment.

The role requires a Bachelor's in Microbiology, 1–3 years of bio-lab experience, and ability to perform Bioburden, LAL, and endotoxin tests, with accurate data reporting and routine QC.

Qualifications

• Bachelor’s degree in Microbiology or related life science.
• 1 year of GMP/ISO/USP exposure.
• 1–3 years of basic microbiological lab testing experience.
• Familiar with USP, FDA, and ISO/ GMP/ USP standards.

Responsibilities

• Prepare and perform microbiological tests on medical devices and pharmaceuticals in accordance with USP, FDA, and ISO regulations.
• Routine quality control of lab equipment, media, and microorganisms.
• Provide accurate test results to customers in a timely manner (Bioburden, LAL Sterility, Off-Site Clean Room Validation).
• Record test results clearly on all documents.
• Technical report writing with tables, graphs, and diagrams.
• Assist in training new Laboratory Technicians.
• Follow qualifications and validations for procedures and equipment.
• Maintain control and tracking of test samples.
• Monitor test status per Work Instructions and SOPs.
• Routine lab cleaning and maintenance.

Skills

GMP familiarit

Detail-oriented

Data analysis

Documentation

Training others

Education

Bachelor’s degree in Microbiology or related life science

Tools

Microscopes

Autoclaves

Water purification systems

Hood operation

Particulate counter

Endotoxin plate reader

Velometers

Balance

Job description

Crown Point, IN, USA

Full-time

Company 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.

Job Description

Candidates in this role are responsible for the accurate and efficient execution of microbiological tests including aseptic processing of sterility tests in a cleanroom suite, particulate matter testing via the use of a laser particle analyzer or microscopic examination, endotoxin testing, or other microbiology pharmaceutical testing in accordance with established procedures. Candidates Will collect and present data in a well-reasoned and accurate manner and maintain the laboratory environment according to cGMP guidelines.

Responsibilities:

• Preparing and performing microbiological tests on medical devices and pharmaceuticals as recommended by current USP, FDA, and AAMI/ISO regulations.

• Routine Quality Control of laboratory equipment, media, and microorganisms.

• Provide accurate test results to customers on a timely basis including but not limited to Bioburden, Limulus amoebocyte lysate (LAL) Sterility for Medical Devices, Off-Site Clean Room Validation and Monitoring, etc.

• Record test results accurately and legibly on all documents.

• Technical report writing including text, tables, graphs, and diagrams.

• Assist in the training of new Laboratory Technicians.

• Follow and perform process qualifications and validations for procedures and/or equipment.

• Maintain control of test samples including logging in, storage, tracking, and disposal.

• Monitor test status and conditions as described in Work Instructions and Operating Procedures.

• Routine maintenance of laboratory environment to include cleaning and troubleshooting.

• Report any deviations and/or nonconformities to Management.

• Suggest possible preventative and corrective measures to prevent future deviations and nonconformities.

• Inventory of laboratory supplies to maintain par levels.

• Perform onsite and offsite testing.

• Gowning and garbing for cleanroom settings.

• In cooperation with the Laboratory Manager, responsible for the qualification, maintenance, and calibration of critical equipment.

• Update procedures for improvement to methods.

• Assist with OOS, NI, CAPA, and Change Control processes in response to Laboratory issues.

• Driving a company car for offsite work, if applicable.

• Other duties as assigned.

Qualifications

Education:

• Bachelor’s degree in Microbiology or related life science

Experience:

• Ideally 1-3 years of experience performing basic microbiological laboratory tests including but not limited to Bioburden, Limulus amoebocyte lysate (LAL) Sterility for Medical Devices, Off-Site Clean Room Validation and Monitoring, etc.

• 1 year of experience with GMP/ISO/USP, etc.

Competencies:

• A highly competent and proficient worker, capable of multi-tasking, being self-motivated, and taking initiative.

• Personal attributes should include honesty, integrity, adaptability, reliability, and positivity.

• Displays leadership skills, is able to train/teach others and possesses high-quality standards.

• Able to provide root cause analysis and corrective action for Out of Specification Results.

• Exhibits troubleshooting skills involving equipment-related issues.

• Maintains personal hygiene and cleanliness inside and outside the microbiology laboratory.

• Adherence to ISO/GMP/USP standards and completion of necessary training modules

• Abilities in mathematical reasoning, arm-hand steadiness, finger dexterity, visual color differences, and deductive reasoning.

• Knowledge of laboratory equipment such as microscopes, velometers, balance, autoclaves, water purification systems, hood operation, particulate counter, membrane filtration, endotoxin plate reader, etc.

• Standard office equipment including computers, copiers, and scanners.

• Frequently requires the use of potentially hazardous chemicals and reagents.

• Must be able to lift up to 30 pounds.

Additional Information

The position is full-time, Monday-Friday, 9:00am-5:00pm, with overtime as needed. Candidates living within a commutable range of Crown Point, IN are encouraged to apply.

• 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 BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.