Sterile Microbiologist - 2nd Shift (Onsite)

Halo Pharma; Northern (KY); Hybrid; USD 110,000 - 140,000; Full time

Job summary

Halo Pharmaceutical in Whippany, NJ is seeking a Microbiologist – Sterile 2nd Shift to support sterile manufacturing operations. You will perform microbiological testing, environmental monitoring, and aseptic process support in a cGMP environment.

Responsibilities include executing microbiology tests (bioburden, endotoxin, sterility), monitoring cleanrooms, assisting validation and CAPA activities, and maintaining compliant documentation. 100% onsite with weekend/extended hours as needed.

Qualifications

• Bachelor’s degree in microbiology or related field required.
• Minimum 10 years microbiology experience in regulated pharma/biotech.
• At least 5 years supporting aseptic/sterile manufacturing operations.
• Experience with startup/commissioning/qualification of aseptic facilities is a plus.

Responsibilities

• Perform daily microbiology lab operations (media prep, cleaning, equipment operation, sample receipt, documentation).
• Conduct routine/specialized micro testing (bioburden, endotoxin, sterility, indicators) per USP.
• Execute environmental monitoring in classified cleanrooms; support gowning and media fill simulations.
• Perform cleaning validation/verification sampling and support process validation for sterile operations.
• Draft/review SOPs, protocols, and risk assessments for regulatory compliance.
• Collaborate with Quality, Manufacturing, and Validation teams to support sterile operations.

Skills

Communication skills

cGMP knowledge

Microbiology

Aseptic manufacturing

Environmental monitoring

Documentation

Lab equipment

MS Office

Education

Bachelor’s degree in microbiology

Tools

TrackWise

SAP

MasterControl

Novatek

Job description

Halo Pharmaceutical in Whippany, NJ is seeking a Microbiologist – Sterile 2nd Shift to support sterile manufacturing operations. You will perform microbiological testing, environmental monitoring, and aseptic process support in a cGMP environment.

Responsibilities include executing microbiology tests (bioburden, endotoxin, sterility), monitoring cleanrooms, assisting validation and CAPA activities, and maintaining compliant documentation. 100% onsite with weekend/extended hours as needed.