Microbiology & Sterilization Validation Specialist (GMP)

Greiner; Monroe (NC); On-site; USD 70,000 - 90,000; Full time

Job summary

Greiner in Monroe, NC seeks a microbiology specialist to perform testing, validations, and environmental monitoring in a GMP laboratory. You will develop SOPs, support CAPA investigations, and participate in audits while ensuring contamination control across facilities.

Requires at least a Bachelor’s or Master’s in microbiology and 3+ years of GMP experience, with knowledge of ISO 13485/ISO 11137 standards and basic computer skills.

Qualifications

• Bachelor’s or Master’s degree in microbiology or related field.
• At least 3 years of GMP-laboratory experience.
• Experience in Medical Device, Pharmaceutical, or regulated industry preferred.
• Knowledge of gamma and ebeam sterilization and ISO 13485/ISO 11137 requirements.
• Basic computer skills (Word, Excel, Outlook) and instrument software.

Responsibilities

• Carry out microbiological testing and examination according to procedures.
• Execute method validations for bioburden and sterilization per ISO standards.
• Lead sterilization validation projects per ISO 11137.
• Support routine dose audits, requalification, dose setting and dose mapping.
• Assist in development of contamination control strategies and gowning program.
• Act as SME for method validation for new products.
• Author SOPs and test procedures and assist in validation reports.
• Data entry for trends and interpretation of sterilization dose audit results.
• Test non-conforming products and investigate via complaint system.
• Support CAPA investigations and internal/regulatory audits.

Skills

GMP experience

Documentation skills

SOP writing

Education

Bachelor’s or Master’s in microbiology or related field

Tools

MS Office

Instrument software

Job description

Greiner in Monroe, NC seeks a microbiology specialist to perform testing, validations, and environmental monitoring in a GMP laboratory. You will develop SOPs, support CAPA investigations, and participate in audits while ensuring contamination control across facilities.

Requires at least a Bachelor’s or Master’s in microbiology and 3+ years of GMP experience, with knowledge of ISO 13485/ISO 11137 standards and basic computer skills.