Job Description

COMPANY OVERVIEW

Halo Pharmaceutical is a technology-focused contract development and manufacturing organization (CDMO) specializing in solid, semi-solid, and liquid dosage forms, with differentiated expertise in controlled substances manufacturing. With facilities in the United States and Canada, Halo supports leading pharmaceutical companies through high-quality manufacturing, operational excellence, and customer-focused solutions.

Join a growing CDMO where your leadership, operational expertise, and ability to drive performance will directly influence site success and customer satisfaction.

POSITION OVERVIEW

The Microbiologist – Sterile 2nd shift is responsible for supporting sterile manufacturing operations by performing microbiological testing, environmental monitoring, and aseptic process support activities. This role ensures compliance with current Good Manufacturing Practices (cGMP), including 21 CFR Parts 210/211, 820, ISO 13485, and EU Annex 1 requirements. The position plays a critical role in maintaining the microbiological control of aseptic processing environments used in the production of sterile injectable products.

100% onsite – 30 N. Jefferson Road, Whippany, NJ

KEY RESPONSIBILITIES

• Perform daily microbiology lab operations (supply ordering, media/disinfectant prep, cleaning, equipment operation, sample receipt, GDP-compliant documentation).

• Conduct routine/specialized micro testing (bioburden, endotoxin/LAL, sterility, biological indicators, growth promotion) per USP, supporting sterile manufacturing, water/steam, and EM programs.

• Execute environmental monitoring (viable air, non-viable particulate, surface/RODAC, personnel) in classified cleanrooms; support aseptic gowning, extended aseptic monitoring, and media fill simulations.

• Perform cleaning validation/verification sampling (swab/rinse) and support process validation for sterile/aseptic operations.

• Conduct microbial identification, gram staining, and colony morphology assessment.

• Maintain working knowledge and application of relevant USP chapters, including USP <51> , <61> , <62> , <71> , <85> , <1035> , and <1111> .

• Support OOS/OOT/EM excursion investigations, root cause analysis, CAPA, and trending/reporting of environmental and utility data.

• Draft/review/revise SOPs, protocols, reports, and risk assessments for regulatory compliance.

• Manage lab operations (media/inventory, equipment cleaning/calibration coordination, sanitation).

• Support internal/customer/regulatory audits; coordinate contract lab sample shipments and review results.

• Ensure proper biohazard/hazardous waste handling; comply with safety, GMP, and company policies.

• Collaborate cross-functionally with Quality, Manufacturing, and Validation teams to support sterile operations.

• Participate in Goods Receipt issuance for microbiology laboratory services as needed.

• Perform other duties as assigned.

POSITION QUALIFICATIONS

• Strong communication skills; able to present effectively across organizational levels and to clients. • Flexible availability, including weekends/extended hours per manufacturing schedules.

• Solid grounding in microbiological principles and sterile/aseptic manufacturing environments; hands-on experience in micro testing and cleanroom environmental monitoring.

• Working knowledge of cGMP, EU Annex 1, and USP methods with required experience in endotoxin, sterility, and bioburden testing; TOC/conductivity/nitrate testing.

• Familiarity with quality systems/software (TrackWise, SAP, MasterControl, Novatek) a plus.

• Self-directed in a fast-paced regulated environment; proper handling/disposal of hazardous and biological lab waste.

• Consistent adherence to safety, housekeeping, cGMP/GLP, and documentation requirements; proper PPE use.

• Collaborative team player with strong attention to detail and accurate, compliant documentation. • Proficient in Microsoft Office (Word, Excel) and lab information systems.

EDUCATION:

• Bachelor’s degree in microbiology, Biology, or a related scientific discipline required. Equivalent experience may be considered.

EXPERIENCE:

Minimum of 10 years of microbiology experience in a regulated pharmaceutical or biotechnology environment. At least 5 years of experience supporting aseptic/sterile manufacturing operations (e.g., vial filling, prefilled syringes, or similar sterile processes) is required. Experience with startup, commissioning, or qualification of aseptic facilities is a plus.

Halo Pharma provides a pay range for this role in accordance with applicable pay transparency laws. Individual pay rates are determined by assessing expertise, skills, education, and professional background

Halo is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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