Microbiologist II
Location: Monroe, North Carolina
Employment Type: Full-Time | Direct Hire
Build Quality Into Products That Make a Difference
Are you an experienced microbiologist ready to take greater ownership of laboratory testing, validation, and contamination-control initiatives?
We are seeking a Microbiologist II to join a collaborative team within a highly regulated manufacturing environment. This is an opportunity to step into a visible, hands-on role where your expertise will directly support product quality, regulatory compliance, and patient safety.
You’ll work on meaningful projects involving microbiological method validation, sterilization, environmental monitoring, and quality investigations. You will also serve as a trusted technical resource, partner with teams across the organization, and help strengthen laboratory processes for both new and existing products.
Benefits
- Medical insurance
- Competitive compensation
- Paid time off in accordance with company policy
- 401(k) with a 5% company match
Why This Opportunity Stands Out
- Take ownership of high-impact sterilization and method-validation projects.
- Expand your experience with gamma and electron-beam sterilization.
- Serve as a microbiology subject matter expert for new-product initiatives.
- Collaborate with quality, manufacturing, and other cross-functional teams.
- Contribute to contamination-control strategies and laboratory improvements.
- Gain valuable exposure to internal audits and external regulatory inspections.
- Join a position where your technical knowledge, ideas, and problem-solving skills will be valued.
What You’ll Do
- Perform microbiological testing according to approved procedures, including bioburden, endotoxin, sterility, growth promotion, cell culture, and environmental monitoring.
- Execute bioburden and sterilization method validations for medical and non-medical devices in accordance with applicable ISO standards.
- Lead sterilization validation projects for new and existing products in accordance with ISO 11137.
- Support routine dose audits, requalification activities, dose-setting studies, and dose-mapping studies.
- Help develop and implement facility and process-monitoring programs that support effective contamination-control strategies.
- Assist with the development and maintenance of facility gowning programs.
- Serve as a subject matter expert for microbiological method validation involving new products.
- Author and revise SOPs, laboratory test procedures, validation protocols, and technical reports.
- Maintain and analyze laboratory data used for trending and management review.
- Interpret sterilization dose-audit results and escalate concerning trends when appropriate.
- Test nonconforming and returned products to support quality investigations and complaint resolution.
- Partner with other departments to investigate deviations, identify root causes, and resolve quality concerns.
- Support corrective and preventive action investigations and implementation.
- Participate in internal audits and assist with external regulatory inspections.
- Conduct aseptic-technique and hygiene-regulation training for employees across the organization.
- Coordinate sample testing with external and third-party laboratories.
- Monitor laboratory supplies, consumables, and equipment.
- Process purchase requisitions and material transfers through SAP.
What You’ll Bring
- Bachelor’s or master’s degree in microbiology or a related scientific field.
- At least three years of relevant experience in a GMP-controlled laboratory environment.
- Experience in the medical device, pharmaceutical, or another highly regulated industry is preferred.
- Knowledge of gamma and electron-beam sterilization.
- Familiarity with ISO 13485 and ISO 11137 requirements.
- Working knowledge of medical-device regulations and applicable industry standards.
- Proficiency with Microsoft Word, Excel, Outlook, and laboratory-specific computer systems.
- Strong analytical, technical-writing, documentation, and problem-solving skills.
- The ability to work independently while building effective partnerships across departments.
Take the Next Step
If you’re looking for a role where you can apply your microbiology expertise, lead important validation work, and make a measurable impact on product quality and safety, we encourage you to apply.