Sterile Microbiology Specialist - 2nd Shift

Halo Pharmaceutical, Inc.; Whippany (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

Halo Pharmaceutical, Inc. is seeking a Microbiologist – Sterile to support 2nd shift operations at our Whippany, NJ facility. The role focuses on microbiological testing, environmental monitoring, and aseptic process support to ensure cGMP compliance for sterile injectable products.

You will work on complex sterile manufacturing activities, maintain tight documentation, and collaborate with Quality, Manufacturing, and Validation teams to uphold product quality and regulatory standards.

Qualifications

• Bachelor’s degree in microbiology or related field required.
• Minimum 10 years of microbiology experience in regulated pharma/biotech.
• At least 5 years supporting aseptic/sterile manufacturing operations.
• Experience with startup/ commissioning of aseptic facilities is a plus.
• Strong communication and documentation skills.
• Proficient in cGMP, EU Annex 1, and USP methods for endotoxin, sterility, bioburden.
• Familiarity with TrackWise, SAP, MasterControl, Novatek is a plus.

Responsibilities

• Perform daily microbiology lab operations and GDP-compliant documentation.
• Conduct micro testing (bioburden, endotoxin, sterility, growth promotion).
• Execute environmental monitoring in classified cleanrooms.
• Support aseptic gowning and media fill simulations.
• Perform cleaning validation sampling and support process validation.
• Conduct microbial identification and gram staining.
• Assist with OOS/OOT/EM investigations and CAPA.
• Draft and revise SOPs and regulatory documents.
• Coordinate audits and lab sample shipments.
• Ensure proper hazardous waste handling and safety compliance.

Skills

Sterile manufacturing

Microbiology testing

Environmental monitoring

Documentation & compliance

Education

Bachelor's degree in Microbiology

Tools

TrackWise

SAP

MasterControl

Novatek

Job description

Halo Pharmaceutical, Inc. is seeking a Microbiologist – Sterile to support 2nd shift operations at our Whippany, NJ facility. The role focuses on microbiological testing, environmental monitoring, and aseptic process support to ensure cGMP compliance for sterile injectable products.

You will work on complex sterile manufacturing activities, maintain tight documentation, and collaborate with Quality, Manufacturing, and Validation teams to uphold product quality and regulatory standards.