Microbiologist II

NEVEON Executive Committee; Monroe (NC); On-site; USD 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a dedicated Microbiologist II to join their innovative team in Monroe. This role involves performing essential microbiological testing and method validations to ensure compliance with ISO standards. You will be instrumental in developing and implementing contamination control strategies while also training colleagues on aseptic techniques. If you are passionate about contributing to quality assurance in the medical device and pharmaceutical industries, this opportunity offers a supportive and inclusive work environment where your expertise will be valued and encouraged.

Qualifications

• 3+ years of experience in a GMP-controlled laboratory environment.
• Knowledge of ISO standards and medical device regulations.

Responsibilities

• Perform microbiological testing and method validations per ISO standards.
• Assist in contamination control strategies and facility monitoring.

Skills

Microbiological Testing

Method Validation

Contamination Control

Data Entry

Aseptic Technique

Education

Bachelor's Degree in Microbiology

Master's Degree in Microbiology

Tools

SAP

Microsoft Word

Microsoft Excel

Microsoft Outlook

Job description

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Microbiologist II

Location: Monroe, US, 28110

Employment Type: Permanent

• Perform microbiological testing and examination according to valid procedures, such as Biobuden, Endotoxin, Sterility, Growth Promotion, and Environmental Monitoring.
• Execute method validations for medical device and non-medical device for bioburden and sterilization according to ISO standards.
• Assist in the development and implementation of processes and facility monitoring to ensure effective contamination control strategies are established.
• Assist in the development of facility gowning program.
• Act as an SME for method validation for new products.
• Author SOPs, test procedures, and assist in creating validation protocols and reports for the lab.
• Data entry for trends and reporting on them for management review.
• Interpretation of sterilization dose audit results and elevation of the data trends as needed.
• Test non-conforming product to resolve QIR issues as well as investigate returned products via complaint processing system.
• Assist in investigations along with other departments to identify root cause.
• Completion of assigned CAPA as needed.
• Conduct aseptic technique training and hygiene regulation training for other departments.
• Review and maintain stock of consumables (supplies and equipment) for Microbiology department.
• Purchase requisition and material transfer in SAP.
• Coordination of sample testing via external/third-party vendor(s).
• Communication and information exchange with affiliated Greiner facilities.
• Other duties as assigned.

Your Profile

• Minimum Bachelor’s or Master’s Degree in microbiology, or related field.
• Minimum 3 years of relevant work experience in GMP-controlled laboratory environment.
• Experience in Medical Device, Pharmaceutical, and/or regulated industry is preferred.
• Basic knowledge of medical device regulation, industry, and international standards.
• Basic understanding of computer systems (Word, Excel, Outlook, and instrument dedicated).
• Knowledge of gamma and ebeam sterilization, and ISO 11137 requirements.

Physical Requirements:
• Must be able to stand and walk for up to 8 hours.
• Must be able to lift up to 70 lbs.

We provide equal opportunities for everyone and see diversity as our strength. Therefore, we welcome all applicants – regardless of identifying characteristics such as gender, age, background, social status, veteran status, sexual orientation, religion, or mental and physical abilities. We have additionally set the goal of empowering women and increasing female leader representation. We foster an inclusive work environment and encourage all individuals to apply.

Job ID: 2558

For visionaries with drive and ideas, for team players who share their knowledge and entertain new ways of thinking, for people who strive for excellence. Our door is always open to achievers, doers, and hidden talents who want to make a difference.