Sterile Manufacturing Operator I – 1st Shift, Growth Path

BioCT Innovation Commons; Northern, Danbury (KY, CT); On-site; USD 40,000 - 55,000; Full time

Job summary

MannKind is seeking a Manufacturing Specialist I for its sterile manufacturing operations. This developmental role provides hands-on learning across the complete process train and requires adherence to cGMP, safety, and quality expectations in a controlled environment.

This 1st shift position runs Monday–Friday, 7:00 am to 3:30 pm and involves batch execution, equipment setup, inspections, and accurate documentation.

Qualifications

• Education and experience aligned for sterile manufacturing roles.
• Ability to read, understand, and execute technical procedures and batch instructions.
• Mechanical aptitude and willingness to learn automated equipment and HMIs.

Responsibilities

• Perform operations per SOPs, batch records, safety requirements and cGMP expectations.
• Support drug product formulation, including staging, dispensing, solution prep, mixing and transfers.
• Clean, wash, inspect, assemble, wrap and store product-contact parts and equipment components.
• Set up the robotic isolator and filling line, monitor cycles, and support line clearance tasks.
• Operate prefilled syringe filling operations and perform in-process checks with documentation.
• Operate visual inspection equipment and perform AVl/Eject inspections per standards.
• Operate the auto-injector assembly system and perform line clearance as qualified.
• Complete batch records, logbooks, forms, labels, and electronic entries accurately.
• Immediately report safety, quality, equipment, environmental, and process concerns.
• Participate in cleaning, monitoring, media fills, validation, and continuous improvement.

Skills

Attention to detail

Technical procedures

Mechanical aptitude

Equipment operation

Documentation accuracy

Communication skills

Problem solving

Education

HS/GED with science/technical experience

BA with science/technical experience

Technical certificate or associate degree preferred

Job description

MannKind is seeking a Manufacturing Specialist I for its sterile manufacturing operations. This developmental role provides hands-on learning across the complete process train and requires adherence to cGMP, safety, and quality expectations in a controlled environment.

This 1st shift position runs Monday–Friday, 7:00 am to 3:30 pm and involves batch execution, equipment setup, inspections, and accurate documentation.