Microbiologist II

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

Responsibility

• Carry out Microbiological testing and examination according to valid procedures; such as Biobuden, Endotoxin, Sterility, Growth Promotion, cell growth (cell culture)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 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 for management review.
• Intrepretation of sterilization dose audit results and elevation of the data trends as needed.
• Test non-conforming product to resolve QIR/NCR issues as well as investigate returned products via complaint processing system.
• Assist in investigations along with other departments to identify root cause.
• Support CAPA investigations by identifying root causes and implementing corrective actions.
• Participate in internal audits and support external regulatory inspections.
• Coduct aspetic technique training and Hygiene regulation training for other departments.
• Review and maintain stock of consumables (supplies and equipment) for Microbiology department.
• Purchase requestion 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.

Job Requirements

• 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 regualtion,industry,and international standards.
• Basic understanding of computer systems (Word, Excel, Outlook, and instrument dedicated).
• Knowledge of gamma and ebeam sterilization, ISO 13485 and ISO 11137 requirements.

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