Specialist II, Sterile Manufacturing Operator; M-F

Position Details

Position: Specialist II, Sterile Manufacturing Operator (M-F, 7am to 3:30pm)

Location: Danbury, CT

Job : 113002

# of Openings: 1

Mann Kind is committed to developing and commercializing innovative therapeutic products for patients living with endocrine and orphan lung diseases. We are on a mission to give people control of their health and the freedom to live life.

At Mann Kind, our employees are our number one asset, and we foster a tight-knit community where each of us plays a critical role in our collective success. We strive to provide a work environment where diversity of background, thought and perspective is valued and respected. Our team is also energized by the company's entrepreneurial spirit that provides an environment in which you can evolve ideas quickly and nimbly.

Our Values serve as the foundation of Mann Kind's culture. They define who we are, how we act, and guide our interactions every day-both with each other and the customers we serve. At Mann Kind, you will work with people who are experts in their fields, see challenges as opportunities, are tenacious and push boundaries, bring creative and solutions-based thinking forward, and always believe in winning together.

The Manufacturing Specialist II is an independently qualified operator responsible for executing sterile manufacturing across the complete process train with limited routine supervision. The role maintains flexible coverage through cross‑training and supports compliant batch execution from formulation through device assembly.

This is a 1st Shift role;
Monday to Friday from 7:00am to 3:30pm.

• Perform assigned operations in accordance with approved SOPs, batch records, work instructions, safety requirements, and cGMP expectations.
• Support drug product formulation, including material staging, dispensing support, solution preparation, mixing, sampling, pH adjustment, filtration, and transfer as qualified.
• Clean, wash, inspect, assemble, wrap, load, sterilize, unload, and store product‑contact change parts and equipment components as qualified.
• Set up the robotic isolator and filling line, load components, perform approved pre‑use checks, initiate and monitor VHP cycles, and support line clearance and readiness activities as qualified.
• Operate and monitor prefilled syringe filling operations, respond to alarms within qualification, perform in‑process checks, reconcile components, and document interventions.
• Operate automated visual inspection equipment and perform qualified manual visual inspection of AVI ejects in accordance with approved defect standards and inspection procedures.
• Operate the auto‑injector assembly system, including component loading, recipe verification, in‑process checks, reject handling, reconciliation, and line clearance as qualified.
• Complete batch records, logbooks, forms, labels, and electronic entries accurately and contemporaneously.
• Immediately report safety, quality, equipment, environmental, documentation, and process concerns.
• Participate in cleaning, environmental and personnel monitoring support, media fills, validation activities, preventive maintenance support, and continuous improvement activities as assigned.
• Independently execute assigned qualified operations and coordinate task sequencing with peers.
• Perform routine trouble response, recovery, and minor adjustments within approved procedures and training.
• Support onboarding and task demonstration for less‑experienced staff when designated.

• Follow approved procedures and maintain good documentation and data integrity practices.
• Identify and promptly escape deviations, atypical conditions, errors, defects,…