EM Group Lead

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 works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

Job Description

• Aseptically collect Environmental Monitoring (EM), cleaning validation, and ICP testing samples at ca biologics facility using sampling protocols and associated documents.
• Ensure compliance with GMP policies and SOPs in a production environment
• Aseptically gown and work in sterile manufacturing areas
• Perform QC testing such as Biourden, Endotoxin,Total Organic Carbon, Concentration, and Conductivity
• Maintain and Ensure sample chain of custody using a LIMS system and perform all aspects of Sample management including aliquotting, storage, receipt, and shipping
• Review manufacturing schedule for dynamic environmental monitoring to ensure all samples are collected appropriately, and address problems where necessary
• Review and reconcile all environmental monitoring samples at the end of the production run to ensure all samples were appropriately taken, processed, and were within required limits
• Weekend, holiday, and overtime work may be required as needed to meet production schedules
• Perform Laboratory and Equipment maintanence
• Participate in lean lab operation, 6S laboratory layout, preventive action, and continuous improvement programs to reduce operating costs
• Calculate, evaluate, review, and properly communicate data verbally and in written format

Qualifications

The Ideal Candidate Would Possess:

• Experience with microbiology, sterile technique, Empower software, and working in a GMP biologics production environment
• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) and attention to detail
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies

Minimum Qualifications

• Bachelor's degree in microbiology, life sciences, or other related degree concentration
• At least 1 year related laboratory experience (microbiology and environmental monitoring in a GMP biologics facility preferred)
• Authorization to work in the United States indefinitely without restriction or sponsorship

Additional Information

What We Offer:

• Comprehensive medical coverage, with dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid holidays and vacation
• Compensation Range: $55,000- $62,000

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