Sterile Manufacturing Specialist II — 1st Shift

BioCT Innovation Commons; Northern, Danbury (KY, CT); On-site; USD 65,000 - 95,000; Full time

Job summary

MannKind is seeking a Manufacturing Specialist II to independently operate sterile manufacturing processes across the full train, with cross-training support to ensure compliant batch execution from formulation through device assembly.

This 1st shift role runs Monday to Friday, 7:00am–3:30pm, and requires GMP manufacturing experience, aseptic processing knowledge, and strong documentation discipline to maintain batch integrity and product quality.

Qualifications

• Demonstrated accuracy in GMP environments and batch records.
• Experience reading and executing technical procedures and batch instructions.
• Familiarity with aseptic processing and cleanroom behavior.

Responsibilities

• Execute sterile manufacturing across the full process train with limited supervision.
• Set up and monitor robotic isolator, filling line, and associated equipment.
• Perform pre-use checks, QA checks, and line clearances for prepared batches.
• Complete batch records, logbooks, forms, and electronic entries accurately and promptly.
• Report safety, quality, and process concerns in a timely manner.
• Support validation activities, investigations, CAPAs, and continuous improvement.

Skills

Attention to detail

Sterile manufacturing

Equipment troubleshooting

Documentation accuracy

Education

HS/GED with 9+ years experience

BA with 2-4 years experience

Tools

Automated equipment

HMIs

VHP cycles

Job description

MannKind is seeking a Manufacturing Specialist II to independently operate sterile manufacturing processes across the full train, with cross-training support to ensure compliant batch execution from formulation through device assembly.

This 1st shift role runs Monday to Friday, 7:00am–3:30pm, and requires GMP manufacturing experience, aseptic processing knowledge, and strong documentation discipline to maintain batch integrity and product quality.