Microbiologist

Accentuate Staffing; Raleigh (NC); On-site; USD 70,000 - 110,000; Full time

Job summary

A leading pharmaceutical manufacturing company is hiring a Microbiologist to join their Raleigh, NC team. This role involves performing microbiological tests, conducting environmental monitoring in cleanrooms, and ensuring compliance with GMP regulations. Candidates should have a Bachelor’s degree in a life science and at least 4 years of experience in a regulated lab environment. This contract-to-hire opportunity offers competitive pay and the chance to work in a dynamic pharmaceutical setting.

Qualifications

• 4+ years of microbiology laboratory experience in a GMP-regulated pharmaceutical or biotech environment.
• Hands-on experience with environmental monitoring in cleanrooms (ISO classified environments preferred).
• Strong working knowledge of cGMPs, USP standards, FDA regulations, and GLPs.
• Experience with LAL testing (kinetic & gel clot), sterility testing.
• Strong knowledge of cGMPs, USP, FDA, and GLPs.
• Experience conducting OOS/OOT investigations and CAPAs.
• Proficiency with LIMS and Microsoft Office.
• Strong written and verbal communication with cross-functional collaboration.

Responsibilities

• Perform microbiological testing including bioburden, endotoxin, and sterility testing.
• Conduct environmental monitoring in classified cleanroom environments.
• Enter, review, and trend laboratory data within LIMS.
• Enter, review, and trend data in LIMS; flag atypical results.
• Investigate OOS/OOT and deviations; support root-cause analysis.
• Assist CAPA implementation and continuous improvement initiatives.
• Support cleaning and process validation and related microbiological studies.
• Maintain laboratory equipment such as autoclaves and particle counters.
• Participate in internal audits and regulatory inspections.
• Train and mentor junior analysts on GMP practices.

Skills

Environmental monitoring

Sterility testing

Endotoxin testing

Data analysis

Cross-functional collaboration

Education

Bachelor’s degree in Microbiology, Biology, or related life science

Tools

LIMS systems

Microsoft Office (Excel, PowerPoint)

Job description

Accentuate Staffing is partnering with a leading pharmaceutical manufacturing company that is hiring for a Microbiologists to join their team. This is a contract-to-hire opportunity offering competitive pay and the opportunity to work in a highly regulated GMP manufacturing environment. The ideal candidate has strong environmental monitoring experience, hands‑on sterility and endotoxin testing expertise, and experience conducting investigations within a pharmaceutical setting.

Multiple shifts available:

• 1st shift: Monday to Friday 6am to 2:30pm
• 2nd shift: Monday to Friday 10am to 6:30pm
• 3rd shift: Monday to Friday 6pm to 2:30am

Responsibilities

1. Perform microbiological testing including bioburden, endotoxin (kinetic turbidimetric & gel clot), particulate matter, and 14-day sterility testing in accordance with USP and internal SOPs.
2. Conduct environmental monitoring in classified cleanroom environments (viable/non-viable air sampling, surface sampling, personnel monitoring).
3. Perform facility water system and clean steam sampling, including microbial and endotoxin testing.
4. Enter, review, and trend laboratory data within LIMS; identify atypical results and elevate as needed.
5. Conduct OOS, OOT, and deviation investigations; support root cause analysis and documentation.
6. Assist with CAPA implementation and continuous improvement initiatives.
7. Support cleaning validation, process validation, and special microbiological studies.
8. Maintain laboratory equipment including autoclaves, glassware washers, particle counters, and isolator systems.
9. Participate in internal audits and regulatory inspections as required.
10. Train and mentor junior analysts on microbiological techniques and GMP compliance.

Requirements

1. Bachelor’s degree in Microbiology, Biology, or related life science.
2. 4+ years of microbiology laboratory experience in a GMP-regulated pharmaceutical or biotech environment.
3. Hands‑on experience with environmental monitoring in cleanrooms (ISO classified environments preferred).
4. Experience with LAL testing (kinetic & gel clot), sterility testing, filtration methods, and particulate matter testing.
5. Strong working knowledge of cGMPs, USP standards, FDA regulations, and GLPs.
6. Experience conducting investigations (OOS/OOT), writing reports, and supporting CAPAs.
7. Proficiency with LIMS systems and Microsoft Office (Excel, PowerPoint, etc.).
8. Strong written and verbal communication skills with ability to collaborate cross‑functionally.