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

MannKind 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 MannKind, 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 MannKind’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 MannKind, 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. Position Summary 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.* 

Essential Duties and Responsibilities

• 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.

Quality System and Compliance Responsibilities

• Follow approved procedures and maintain good documentation and data integrity practices.
• Identify and promptly escalate deviations, atypical conditions, errors, defects, alarms, and potential product-quality risks.
• Support investigations, CAPAs, change controls, risk assessments, procedure revisions, and inspection readiness activities at a level appropriate to qualification and experience.
• Maintain all required curriculum, gowning, aseptic, equipment, safety, and visual inspection qualifications.

Minimum Qualifications

Education	HS/GED with 9+ years’ experience or BA with 2-4 years’ experience in a scientific/technical area or the combination equivalent of training and experience. Relevant technical certificate or associate degree preferred.
Experience	2+ years of GMP manufacturing experience, preferably in sterile pharmaceutical, biotechnology, fill-finish, combination-product, or similarly regulated operations.

Required Knowledge, Skills, and Abilities

• Strong attention to detail and commitment to patient safety, product quality, and reliable execution.
• Working knowledge of sterile drug product manufacturing, aseptic processing, contamination control, and cleanroom behavior. EU Annex 1, US FDA 21CFR Parts 210/211, USP <790>, <1790>,
• Ability to read, understand, and execute technical procedures and batch instructions.
• Mechanical aptitude and ability to learn automated equipment, HMIs, alarms, sensors, and basic troubleshooting.
• Ability to perform accurate calculations and complete clear, compliant documentation.
• Ability to pass a visual acuity check for qualification of visual inspection to meet 20/20 near vision (natural or corrected)
• Ability to communicate effectively, work collaboratively, accept coaching, and escalate concerns promptly.
• Ability to distinguish relevant defects for visual inspection after successful completion of required qualification and periodic requalification.
• Demonstrated independent qualification in designated formulation, component preparation, filling, inspection, and assembly operations.

Physical and Work Environment Requirements

• Ability to work in classified cleanroom environments and wear required gowning and personal protective equipment for extended periods.
• Ability to stand, walk, reach, bend, and perform repetitive tasks for extended periods.
• Ability to lift and move materials within company-defined safe-lifting limits, with assistance or mechanical aids when required.
• Ability to work around cleaning agents, sanitizers, disinfectants, and VHP-controlled equipment in accordance with approved safety procedures.
• Ability to work the assigned schedule and modified schedules during qualifications, media fills, campaigns, shutdowns, or business-critical events.

The duties and responsibilities described above are not intended to be an exhaustive list. Additional duties may be assigned based on business needs. Reasonable accommodation may be made to enable qualified individuals to perform the essential functions of the position.