Specialist II, Sterile Manufacturing Operator (M-F, 7am to 3:30pm)
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). Use - for any list of duties/requirements/benefits, and
for prose. Do NOT repeat the job title as a heading. Do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones.
We need to decide which sections to include. The posting includes:
- Intro about MannKind (mission, values, culture). Could be "About the role" or maybe "About MannKind". The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we can use "About the role" for the company description.
- Position Summary: description of role. Could be part of "About the role" or separate "Position Summary". But we can incorporate into "About the role" or "Responsibilities". However they said use headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we can have sections: About the role (company overview + position summary), Responsibilities (list of essential duties), Requirements (minimum qualifications), Qualifications (maybe knowledge, skills, abilities), Skills (maybe required knowledge, skills, abilities). But we need to avoid thin sections. Perhaps combine Requirements and Qualifications into one "Requirements" section. Or we can have "Qualifications" for education/experience, and "Skills" for knowledge, skills, abilities. The posting includes "Minimum Qualifications", "Experience", "Required Knowledge, Skills, And Abilities", "Physical And Work Environment Requirements". So we could have sections: Qualifications (education/experience), Skills (knowledge, skills, abilities), and maybe "Physical Requirements" but not in list of allowed headings. The allowed headings are limited; we could put physical requirements under "Qualifications" or "Skills". But better to follow allowed headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule.
We have Pay info: Pay Range: $35.40 - $53.10 per hour. So we need a Pay section.
Schedule: The posting says "This is a 1st Shift role; Monday to Friday from 7:00am to 3:30pm.*". So we have schedule info. So we need a Schedule section.
Benefits: Not mentioned. So we should NOT create a Benefits section.
Thus sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Pay, Schedule.
We need to ensure we don't create empty sections.
Now we need to extract content.
About the role: Should include MannKind mission, values, culture, and position summary. Let's combine.
Paragraph: "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."
Then 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.*"
But schedule will be separate; we might not repeat schedule in About the role. However we can keep position summary without schedule, but the summary includes schedule. Since we have a separate Schedule section, we could omit schedule from About the role to avoid duplication. But we must preserve ALL substantive information; we can't omit schedule entirely; we need to include it somewhere. So we can keep schedule in the Schedule section and not repeat it in About the role. However the position summary sentence includes schedule; we could split: keep the rest of position summary without schedule, and put schedule in Schedule section. That's okay as we are not omitting info, just relocating.
Thus About the role content: MannKind mission etc + position summary without schedule.
Let's craft:
"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.
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."
Now Responsibilities: list of essential duties. We need to extract bullet points from "Essential Duties And Responsibilities". They are many sentences each starting with a verb. We'll make
- for each.
List:
- 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.
We could also include "Quality System And Compliance Responsibilities" as part of responsibilities? Might be separate but we can incorporate into Responsibilities as additional bullets.
Quality System And Compliance Responsibilities bullets:
- 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.
We'll add those as li.
Now Requirements: maybe combine education/experience etc. The posting has "Minimum Qualifications", "Experience", "Required Knowledge, Skills, And Abilities", "Physical And Work Environment Requirements". We need to decide sections: Qualifications (education/experience), Skills (knowledge, skills, abilities), Requirements maybe for physical? But we have allowed headings: Requirements, Qualifications, Skills. We could put education/experience under Qualifications, knowledge/skills/abilities under Skills, and physical/work environment under Requirements. Or we could merge.
Let's follow: Qualifications: education/experience. Skills: knowledge, skills, abilities. Requirements: physical and work environment requirements.
Thus:
Qualifications section: include Minimum Qualifications and Experience.
Content: "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. Experience Relevant technical certificate or associate degree preferred. 2+ years of GMP manufacturing experience, preferably in sterile pharmaceutical, biotechnology, fill-finish, combination-product, or similarly regulated operations."
We need to preserve all detail. We'll put as
maybe.
Skills section: Required Knowledge, Skills, And Abilities bullets.
List:
- 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 , , (looks like missing specifics; but we keep as is)
- 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.
Note: The line "EU Annex 1, US FDA 21CFR Parts 210/211, USP , ," seems incomplete; we keep as is.
Now Requirements section: Physical And Work Environment Requirements bullets.
List:
- 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
for prose. Do NOT repeat the job title as a heading. Do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. Preserve ALL substantive information; do NOT invent or summarize away detail. Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, and application instructions. IMPORTANT: include a section ONLY when the posting has real, specific content for it — never emit a heading followed by filler/placeholder text (e.g. "commensurate with experience", "not specified", "N/A", "varies", "TBD") and never create Pay/Schedule/Benefits sections unless the posting actually states them. Prefer a few substantive sections over many thin ones. We need to decide which sections to include. The posting includes: - Intro about MannKind (mission, values, culture). Could be "About the role" or maybe "About MannKind". The instruction says use headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we can use "About the role" for the company description. - Position Summary: description of role. Could be part of "About the role" or separate "Position Summary". But we can incorporate into "About the role" or "Responsibilities". However they said use headings for sections like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we can have sections: About the role (company overview + position summary), Responsibilities (list of essential duties), Requirements (minimum qualifications), Qualifications (maybe knowledge, skills, abilities), Skills (maybe required knowledge, skills, abilities). But we need to avoid thin sections. Perhaps combine Requirements and Qualifications into one "Requirements" section. Or we can have "Qualifications" for education/experience, and "Skills" for knowledge, skills, abilities. The posting includes "Minimum Qualifications", "Experience", "Required Knowledge, Skills, And Abilities", "Physical And Work Environment Requirements". So we could have sections: Qualifications (education/experience), Skills (knowledge, skills, abilities), and maybe "Physical Requirements" but not in list of allowed headings. The allowed headings are limited; we could put physical requirements under "Qualifications" or "Skills". But better to follow allowed headings: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We have Pay info: Pay Range: $35.40 - $53.10 per hour. So we need a Pay section. Schedule: The posting says "This is a 1st Shift role; Monday to Friday from 7:00am to 3:30pm.*". So we have schedule info. So we need a Schedule section. Benefits: Not mentioned. So we should NOT create a Benefits section. Thus sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Pay, Schedule. We need to ensure we don't create empty sections. Now we need to extract content. About the role: Should include MannKind mission, values, culture, and position summary. Let's combine. Paragraph: "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." Then 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.*" But schedule will be separate; we might not repeat schedule in About the role. However we can keep position summary without schedule, but the summary includes schedule. Since we have a separate Schedule section, we could omit schedule from About the role to avoid duplication. But we must preserve ALL substantive information; we can't omit schedule entirely; we need to include it somewhere. So we can keep schedule in the Schedule section and not repeat it in About the role. However the position summary sentence includes schedule; we could split: keep the rest of position summary without schedule, and put schedule in Schedule section. That's okay as we are not omitting info, just relocating. Thus About the role content: MannKind mission etc + position summary without schedule. Let's craft: "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. 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." Now Responsibilities: list of essential duties. We need to extract bullet points from "Essential Duties And Responsibilities". They are many sentences each starting with a verb. We'll make
- for each.
List:
- 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.
We could also include "Quality System And Compliance Responsibilities" as part of responsibilities? Might be separate but we can incorporate into Responsibilities as additional bullets.
Quality System And Compliance Responsibilities bullets:
- 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.
We'll add those as li.
Now Requirements: maybe combine education/experience etc. The posting has "Minimum Qualifications", "Experience", "Required Knowledge, Skills, And Abilities", "Physical And Work Environment Requirements". We need to decide sections: Qualifications (education/experience), Skills (knowledge, skills, abilities), Requirements maybe for physical? But we have allowed headings: Requirements, Qualifications, Skills. We could put education/experience under Qualifications, knowledge/skills/abilities under Skills, and physical/work environment under Requirements. Or we could merge.
Let's follow: Qualifications: education/experience. Skills: knowledge, skills, abilities. Requirements: physical and work environment requirements.
Thus:
Qualifications section: include Minimum Qualifications and Experience.
Content: "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. Experience Relevant technical certificate or associate degree preferred. 2+ years of GMP manufacturing experience, preferably in sterile pharmaceutical, biotechnology, fill-finish, combination-product, or similarly regulated operations."
We need to preserve all detail. We'll put as
maybe. Skills section: Required Knowledge, Skills, And Abilities bullets. List: - 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 , , (looks like missing specifics; but we keep as is) - 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. Note: The line "EU Annex 1, US FDA 21CFR Parts 210/211, USP , ," seems incomplete; we keep as is. Now Requirements section: Physical And Work Environment Requirements bullets. List: - 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