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A Microbiologist II role in Monroe, NC, focused on hands-on microbiology, sterilization validation, and regulatory-compliant laboratory operations. The position supports environmental monitoring, CAPA, investigations, and continuous improvement.
The candidate will contribute to product quality and patient safety, coordinating with Quality, Manufacturing, and Engineering teams while maintaining SOPs and technical documentation.
Location: Monroe, North Carolina
Employment Type: Full-Time | Direct Hire
We are seeking an experienced Microbiologist II to join a quality-focused team in a highly regulated manufacturing environment. This position offers the opportunity to take an active role in microbiological testing, sterilization validation, environmental monitoring, contamination control, and laboratory quality initiatives that directly support product safety and regulatory compliance.
This is an excellent opportunity for a microbiologist who enjoys hands-on laboratory work but is also ready to take greater ownership of validation projects, investigations, technical documentation, and process improvements .
In this position, you'll have the opportunity to:
Lead and support critical sterilization and microbiological validation activities
Develop additional expertise with gamma and electron-beam sterilization
Act as a technical resource for microbiology and new-product initiatives
Work closely with Quality, Manufacturing, Engineering, and other teams
Participate in contamination-control and environmental-monitoring programs
Contribute to investigations, CAPAs, and continuous improvement initiatives
Gain exposure to both internal audits and external regulatory inspections
Make a direct contribution to product quality, compliance, and patient safety
As a Microbiologist II, you will perform and oversee a variety of laboratory and quality activities, including:
Conduct microbiological testing such as bioburden, endotoxin, sterility, growth promotion, cell culture, and environmental monitoring
Perform microbiological method validations for medical and non-medical devices
Lead and support sterilization validation activities in accordance with ISO 11137
Participate in dose audits, dose-setting studies, dose mapping, and sterilization requalification
Evaluate sterilization results and identify or elevate trends requiring further investigation
Support the development and ongoing improvement of contamination-control and facility-monitoring programs
Assist with facility gowning requirements and programs
Serve as a microbiology resource and subject matter expert (SME) for new-product activities
Prepare and maintain SOPs, laboratory procedures, validation protocols, and technical reports
Review and trend microbiological laboratory data for quality and management reporting
Perform testing on returned or nonconforming products in support of investigations and complaint resolution
Participate in deviation investigations, root-cause analysis, and CAPA activities
Work cross-functionally to resolve microbiological and product-quality concerns
Support internal quality audits and external regulatory inspections
Provide training related to aseptic technique, hygiene requirements, and microbiological practices
Coordinate specialized testing with outside and third-party laboratories
Maintain appropriate laboratory inventory, equipment, supplies, and consumables
Use SAP to support purchase requisitions and material-transfer activities
The ideal candidate will bring a strong foundation in microbiology along with experience working within a regulated laboratory environment.
Bachelor's or master's degree in Microbiology or a related scientific discipline
Minimum of 3 years of relevant experience in a GMP-regulated laboratory environment
Medical device, pharmaceutical, life sciences, or comparable regulated-industry experience preferred
Experience or working knowledge of gamma and electron-beam sterilization
Knowledge of ISO 13485 and ISO 11137
Understanding of medical-device regulations and applicable quality requirements
Experience with microbiological testing, validation, and laboratory documentation
Strong technical-writing, analytical, investigation, and problem-solving abilities
Proficiency with Microsoft Word, Excel, Outlook, and laboratory-based computer systems
Ability to independently manage responsibilities while collaborating effectively with cross-functional teams
We offer a competitive total rewards package that includes:
Competitive compensation
Medical insurance
Paid time off in accordance with company policy
401(k) with a 5% company match
$60,000.00 to $75,000.00 per year
Equal Opportunity Employer/Veterans/Disabled
Military connected talent encouraged to apply
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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:
The California Fair Chance Act
Los Angeles City Fair Chance Ordinance
Los Angeles County Fair Chance Ordinance for Employers
San Francisco Fair Chance Ordinance
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.