Microbiologist II — Sterilization & Validation Expert

NEVEON Executive Committee; Monroe, Northern (NC, KY); Hybrid; USD 70,000 - 90,000; Full time

Job summary

Greiner Bio-One in Monroe, NC is seeking a Microbiologist II for a permanent role in a GMP-controlled laboratory environment. The role requires a minimum of a Bachelor's or Master’s degree in microbiology and at least 3 years of related experience, with preference for medical device or pharmaceutical industry background.

You will perform extensive microbiological testing, validations per ISO standards, and lead sterilization validation projects while supporting CAPA, audits, and regulatory

Qualifications

• Bachelor's or Master's degree in microbiology or related field.
• 3+ years of relevant GMP-controlled laboratory experience.
• Experience in Medical Device, Pharmaceutical, and/or regulated industry preferred.
• Knowledge of ISO 13485 and ISO 11137 requirements.

Responsibilities

• Carry out microbiological testing and examination according to valid procedures (Biobuden, Endotoxin, Sterility, Growth Promotion, cell growth and Environmental Monitoring).
• Execute method validations for medical device and non-medical device for bioburden and sterilization according to ISO standards.
• Lead sterilization validation projects for new and existing products according to ISO 11137.
• Support routine dose audits, requalification, dose setting and dose mapping studies.
• Assist in development and implementation of processes and facility monitoring for contamination control.
• Assist in development of facility gowning program.

Education

Bachelor's or Master's Degree in microbiology or related field

Job description

Greiner Bio-One in Monroe, NC is seeking a Microbiologist II for a permanent role in a GMP-controlled laboratory environment. The role requires a minimum of a Bachelor's or Master’s degree in microbiology and at least 3 years of related experience, with preference for medical device or pharmaceutical industry background.

You will perform extensive microbiological testing, validations per ISO standards, and lead sterilization validation projects while supporting CAPA, audits, and regulatory