Process Associate I - Biotech Manufacturing
BioSpace · West Lebanon, NH · 3 wk ago
ManagementFull-time
We need to output HTML fragment with headings for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title. Must preserve all substantive info, no boilerplate. Remove cookie/navigation/legal/EEO etc. Also remove duplicated lines. Must not create sections with filler like "commensurate with experience". Must include sections only if posting has real specific content.
We need to parse the posting.
Let's extract sections:
- About The Department Site New Hampshire... This is about the department/site. Could be "About the role"? Actually "About The Department Site New Hampshire" is description of site. Could be considered "About the role"? The instruction: use
for sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. We must not repeat job title. Must preserve all substantive info, no boilerplate. Remove cookie/navigation/legal/EEO etc. Also remove duplicated lines. Must not create sections with filler like "commensurate with experience". Must include sections only if posting has real specific content.
We need to parse the posting.
Let's extract sections:
- About The Department Site New Hampshire... This is about the department/site. Could be "About the role"? Actually "About The Department Site New Hampshire" is description of site. Could be considered "About the role"? The instruction: use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we need to map content to these headings.
We have:
- "What We Offer You" includes benefits: Leading pay and annual performance bonus for all positions, 36 Paid days off including vacation, sick days & company holidays, Health Insurance, Dental Insurance, Vision Insurance, Guaranteed 8% 401K contribution plus individual company match option, 14 weeks Paid Parental Leave, Free access to Novo Nordisk-marketed pharmaceutical products, opportunities, resources and mentorship to grow and build your career.
Thus Benefits section: we can list these bullet points.
Pay: "Leading pay and annual performance bonus for all positions" is pay info. Could be separate Pay section. But we also have "Leading pay and annual performance bonus". Might be considered Pay. However we also have benefits separate. The instruction: Prefer a few substantive sections over many thin ones. Could combine Pay and Benefits? But they said use headings for Benefits, Pay, Schedule separately if content exists. We have pay info: "Leading pay and annual performance bonus for all positions". That's specific enough for Pay section. Benefits: list of days off, insurance, 401k, parental leave, free access to products, mentorship.
Schedule: "This is an onsite based position Monday-Friday at our bioproduction facility in West Lebanon, NH." Also maybe on-call rotations: "Participate in on-call rotations, including weekends and non-business hours, to provide support". So schedule info includes Monday-Friday onsite, plus on-call rotations.
Thus we can have Schedule section.
Now Responsibilities: The posting includes many responsibilities under "Essential Functions" and also earlier description: "This position has primary responsibility to support manufacturing operations in one of our downstream process support teams. Focus areas may include Training, Documentation, Deviations, Change Control and Projects. Drives the coordination and execution of process and equipment improvement initiatives, reviews completed quality records, generates quality deviation responses, drive investigations and has ability to train technicians on processes and QMS systems. Responsible for supporting production through on-floor knowledge and support, documentation to keep production running efficiently, and supporting training of technicians to run according to cGMP requirements. This role will work cross functionally with groups/departments across our site to ensure operational efficiencies and successful production of API. This role will require entering our sterile cleanroom areas while following all relevant gowning, safety, and quality policies."
Then under Essential Functions list many bullet-like sentences. We'll need to convert to - .
Requirements: The posting includes "Qualifications" section with Education and Certifications, Work Experience, Knowledge, Skills and Abilities, Physical Requirements. We need to separate into Requirements, Qualifications, Skills perhaps. The instruction says use headings for Requirements, Qualifications, Skills. So we need to decide what goes where.
Typically: Requirements could be education/experience; Qualifications could be preferred qualifications; Skills could be knowledge, skills and abilities. But we need to follow the posting content.
We have:
Education and Certifications: High School diploma or equivalent required; Bachelor’s degree in science or engineering preferred.
Work Experience: High School diploma or equivalent with six (6) years relevant manufacturing experience required; Bachelor’s degree or equivalent with two (2) years of experience preferred; Pharmaceutical Or Biotechnology Experience Strongly Preferred.
Knowledge, Skills and Abilities: list of items.
Physical Requirements: list.
Thus we could map:
- Requirements: Education and Certifications + Work Experience (maybe combined as requirements). Or we could separate: Requirements = Education and Experience; Qualifications = Preferred (Bachelor's degree, etc). But the instruction says we can have both Requirements and Qualifications sections if there is real specific content. We have both required and preferred items. So we can put required items under Requirements, and preferred items under Qualifications. Skills: Knowledge, Skills and Abilities.
Physical Requirements maybe could be part of Requirements or separate? There's no heading for Physical Requirements in the list; we could include under Requirements or maybe under Skills? But better to include under Requirements as a subsection? However we must only use allowed headings. Could we add a
inside Requirements for physical requirements? Yes, we can include paragraphs.
Thus:
Requirements
Education and Certifications: High School diploma or equivalent required; Bachelor’s degree in science or engineering preferred.
Work Experience: High School diploma or equivalent with six (6) years relevant manufacturing experience required; Bachelor’s degree or equivalent with two (2) years of experience preferred; Pharmaceutical Or Biotechnology Experience Strongly Preferred.
Physical Requirements: 0-10% overnight travel required; ability to finger, climb and walk; ability to speak, listen and understand verbal and written communication; while performing this job employee work involves sitting most of the time with walking and standing required only occasionally; may lift up to 10 pounds frequently or constantly; visual acuity to perform close activities such as reading, writing and analysing; and to determine the accuracy, neatness and thoroughness of work assigned or to make general observations.
Then Qualifications: maybe we can include preferred qualifications like "Bachelor’s degree in science or engineering preferred" but we already used that. Actually we could treat Qualifications as "Preferred qualifications" like "Bachelor’s degree or equivalent with two (2) years of experience preferred" and "Pharmaceutical Or Biotechnology Experience Strongly Preferred". But we already included those in Work Experience. Might be redundant. Perhaps better: Requirements = required items (HS diploma, 6 years experience). Qualifications = preferred items (Bachelor's degree, 2 years experience, pharma/biotech experience). Skills = Knowledge, Skills and Abilities list.
Let's decide:
Requirements (required):
- High School diploma or equivalent required.
- Six (6) years relevant manufacturing experience required.
Qualifications (preferred):
- Bachelor’s degree in science or engineering preferred.
- Bachelor’s degree or equivalent with two (2) years of experience preferred.
- Pharmaceutical Or Biotechnology Experience Strongly Preferred.
Skills (Knowledge, Skills and Abilities):
- Functional understanding of cGMPs, established manufacturing practices and procedures and compliance with quality regulations and guidelines.
- Ability to understand and execute established written instructions is essential.
- Organizational skills and an ability to perform assignments with a high degree of attention to detail.
- Demonstrate a practical understanding of lean manufacturing principles.
- Analytical Abilities And Problem-solving Skills.
- Excellent communication skills-articulates ideas and concepts clearly to all audiences.
- Employee must remain accessible during on-call period and must be able to provide support/respond within sixty (60) minutes.
Physical Requirements could be placed under Requirements as a paragraph, or maybe under a separate section but we don't have heading. We'll include under Requirements as a paragraph.
Now Responsibilities: we need to capture all responsibilities from the description and Essential Functions list.
Let's extract responsibilities:
From earlier paragraph:
- Support manufacturing operations in one of our downstream process support teams.
- Focus areas may include Training, Documentation, Deviations, Change Control and Projects.
- Drives the coordination and execution of process and equipment improvement initiatives.
- Reviews completed quality records.
- Generates quality deviation responses.
- Drives investigations.
- Has ability to train technicians on processes and QMS systems.
- Supports production through on-floor knowledge and support.
- Provides documentation to keep production running efficiently.
- Supports training of technicians to run according to cGMP requirements.
- Works cross functionally with groups/departments across our site to ensure operational efficiencies and successful production of API.
- Enters sterile cleanroom areas while following all relevant gowning, safety, and quality policies.
From Essential Functions (list):
- Liaison between Production Support and Manufacturing for the coordination of process/equipment improvements and data trending/analysis.
- Review/approval of completed process documentation.
- Ability to train others on the manufacturing process and QMS systems.
- Revise and create documentation (SOP, batch records, FT’s) associated with the manufacture of product, requiring minimal direction.
- Ability to investigate and write up Deviation events utilizing Root Cause Analysis.
- Incorporate pre-planned process improvements and cost reduction projects into manufacturing.
- Ability to take on and manage multi-disciplined projects, with minimal supervision.
- Understanding/application of quality systems.
- Support of Health Authority inspections.
- Possesses technical and systems knowledge and can research information outside of knowledge base.
- May need to support hands-on manufacturing within the given area for production coverage.
- Has ability to recognize problems and recommend solutions to problems based on technical understanding of the process and equipment.
- Support activities in other departments as instructed by manager.
- Participate in on-call rotations, including weekends and non-business hours, to provide support.
- Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes.
- Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others.
- Other duties as assigned.
We need to output these as - items.
Now Benefits: we have list from "What We Offer You". Let's extract:
- Leading pay and annual performance bonus for all positions (but we might put pay separately)
- 36 Paid days off including vacation, sick days & company holidays
- Health Insurance, Dental Insurance, Vision Insurance
- Guaranteed 8% 401K contribution plus individual company match option
- 14 weeks Paid Parental Leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Opportunities, resources and mentorship to grow and build your career.
We could separate Pay: "Leading pay and annual performance bonus for all positions". Benefits: rest.
Schedule: "This is an onsite based position Monday-Friday at our bioproduction facility in West Lebanon, NH." plus "Participate in on-call rotations, including weekends and non-business hours, to provide support." So schedule includes regular Monday-Friday onsite, plus on-call rotations.
Now About the role: maybe we can use the initial paragraph about department/site? Actually "About The Department Site New Hampshire..." is about the site. Could be considered "About the role"? But we already have responsibilities etc. The instruction says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should include an About the role section with a brief description of the role. The posting includes: "The Position This position has primary responsibility to support manufacturing operations in one of our downstream process support teams. Focus areas may include Training, Documentation, Deviations, Change Control and Projects. Drives the coordination and execution of process and equipment improvement initiatives, reviews completed quality records, generates quality deviation responses, drive investigations and has ability to train technicians on processes and QMS systems. Responsible for supporting production through on-floor knowledge and support, documentation to keep production running efficiently, and supporting training of technicians to run according to cGMP requirements. This role will work cross functionally with groups/departments across our site to ensure operational efficiencies and successful production of API. This role will require entering our sterile cleanroom areas while following all relevant gowning, safety, and quality policies. This is an onsite based position Monday-Friday at our bioproduction facility in West Lebanon, NH."
That could be About the role. However we also have Responsibilities separate. To avoid duplication, we could put a concise summary
- .
Requirements: The posting includes "Qualifications" section with Education and Certifications, Work Experience, Knowledge, Skills and Abilities, Physical Requirements. We need to separate into Requirements, Qualifications, Skills perhaps. The instruction says use headings for Requirements, Qualifications, Skills. So we need to decide what goes where.
Typically: Requirements could be education/experience; Qualifications could be preferred qualifications; Skills could be knowledge, skills and abilities. But we need to follow the posting content.
We have:
Education and Certifications: High School diploma or equivalent required; Bachelor’s degree in science or engineering preferred.
Work Experience: High School diploma or equivalent with six (6) years relevant manufacturing experience required; Bachelor’s degree or equivalent with two (2) years of experience preferred; Pharmaceutical Or Biotechnology Experience Strongly Preferred.
Knowledge, Skills and Abilities: list of items.
Physical Requirements: list.
Thus we could map:
- Requirements: Education and Certifications + Work Experience (maybe combined as requirements). Or we could separate: Requirements = Education and Experience; Qualifications = Preferred (Bachelor's degree, etc). But the instruction says we can have both Requirements and Qualifications sections if there is real specific content. We have both required and preferred items. So we can put required items under Requirements, and preferred items under Qualifications. Skills: Knowledge, Skills and Abilities.
Physical Requirements maybe could be part of Requirements or separate? There's no heading for Physical Requirements in the list; we could include under Requirements or maybe under Skills? But better to include under Requirements as a subsection? However we must only use allowed headings. Could we add a
inside Requirements for physical requirements? Yes, we can include paragraphs. Thus:
Requirements
Education and Certifications: High School diploma or equivalent required; Bachelor’s degree in science or engineering preferred.
Work Experience: High School diploma or equivalent with six (6) years relevant manufacturing experience required; Bachelor’s degree or equivalent with two (2) years of experience preferred; Pharmaceutical Or Biotechnology Experience Strongly Preferred.
Physical Requirements: 0-10% overnight travel required; ability to finger, climb and walk; ability to speak, listen and understand verbal and written communication; while performing this job employee work involves sitting most of the time with walking and standing required only occasionally; may lift up to 10 pounds frequently or constantly; visual acuity to perform close activities such as reading, writing and analysing; and to determine the accuracy, neatness and thoroughness of work assigned or to make general observations.
Then Qualifications: maybe we can include preferred qualifications like "Bachelor’s degree in science or engineering preferred" but we already used that. Actually we could treat Qualifications as "Preferred qualifications" like "Bachelor’s degree or equivalent with two (2) years of experience preferred" and "Pharmaceutical Or Biotechnology Experience Strongly Preferred". But we already included those in Work Experience. Might be redundant. Perhaps better: Requirements = required items (HS diploma, 6 years experience). Qualifications = preferred items (Bachelor's degree, 2 years experience, pharma/biotech experience). Skills = Knowledge, Skills and Abilities list. Let's decide: Requirements (required): - High School diploma or equivalent required. - Six (6) years relevant manufacturing experience required. Qualifications (preferred): - Bachelor’s degree in science or engineering preferred. - Bachelor’s degree or equivalent with two (2) years of experience preferred. - Pharmaceutical Or Biotechnology Experience Strongly Preferred. Skills (Knowledge, Skills and Abilities): - Functional understanding of cGMPs, established manufacturing practices and procedures and compliance with quality regulations and guidelines. - Ability to understand and execute established written instructions is essential. - Organizational skills and an ability to perform assignments with a high degree of attention to detail. - Demonstrate a practical understanding of lean manufacturing principles. - Analytical Abilities And Problem-solving Skills. - Excellent communication skills-articulates ideas and concepts clearly to all audiences. - Employee must remain accessible during on-call period and must be able to provide support/respond within sixty (60) minutes. Physical Requirements could be placed under Requirements as a paragraph, or maybe under a separate section but we don't have heading. We'll include under Requirements as a paragraph. Now Responsibilities: we need to capture all responsibilities from the description and Essential Functions list. Let's extract responsibilities: From earlier paragraph: - Support manufacturing operations in one of our downstream process support teams. - Focus areas may include Training, Documentation, Deviations, Change Control and Projects. - Drives the coordination and execution of process and equipment improvement initiatives. - Reviews completed quality records. - Generates quality deviation responses. - Drives investigations. - Has ability to train technicians on processes and QMS systems. - Supports production through on-floor knowledge and support. - Provides documentation to keep production running efficiently. - Supports training of technicians to run according to cGMP requirements. - Works cross functionally with groups/departments across our site to ensure operational efficiencies and successful production of API. - Enters sterile cleanroom areas while following all relevant gowning, safety, and quality policies. From Essential Functions (list): - Liaison between Production Support and Manufacturing for the coordination of process/equipment improvements and data trending/analysis. - Review/approval of completed process documentation. - Ability to train others on the manufacturing process and QMS systems. - Revise and create documentation (SOP, batch records, FT’s) associated with the manufacture of product, requiring minimal direction. - Ability to investigate and write up Deviation events utilizing Root Cause Analysis. - Incorporate pre-planned process improvements and cost reduction projects into manufacturing. - Ability to take on and manage multi-disciplined projects, with minimal supervision. - Understanding/application of quality systems. - Support of Health Authority inspections. - Possesses technical and systems knowledge and can research information outside of knowledge base. - May need to support hands-on manufacturing within the given area for production coverage. - Has ability to recognize problems and recommend solutions to problems based on technical understanding of the process and equipment. - Support activities in other departments as instructed by manager. - Participate in on-call rotations, including weekends and non-business hours, to provide support. - Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes. - Incorporates the Novo Nordisk Way and 10 Essentials in all activities and interactions with others. - Other duties as assigned. We need to output these as- items.
Now Benefits: we have list from "What We Offer You". Let's extract:
- Leading pay and annual performance bonus for all positions (but we might put pay separately)
- 36 Paid days off including vacation, sick days & company holidays
- Health Insurance, Dental Insurance, Vision Insurance
- Guaranteed 8% 401K contribution plus individual company match option
- 14 weeks Paid Parental Leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Opportunities, resources and mentorship to grow and build your career.
We could separate Pay: "Leading pay and annual performance bonus for all positions". Benefits: rest.
Schedule: "This is an onsite based position Monday-Friday at our bioproduction facility in West Lebanon, NH." plus "Participate in on-call rotations, including weekends and non-business hours, to provide support." So schedule includes regular Monday-Friday onsite, plus on-call rotations.
Now About the role: maybe we can use the initial paragraph about department/site? Actually "About The Department Site New Hampshire..." is about the site. Could be considered "About the role"? But we already have responsibilities etc. The instruction says use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we should include an About the role section with a brief description of the role. The posting includes: "The Position This position has primary responsibility to support manufacturing operations in one of our downstream process support teams. Focus areas may include Training, Documentation, Deviations, Change Control and Projects. Drives the coordination and execution of process and equipment improvement initiatives, reviews completed quality records, generates quality deviation responses, drive investigations and has ability to train technicians on processes and QMS systems. Responsible for supporting production through on-floor knowledge and support, documentation to keep production running efficiently, and supporting training of technicians to run according to cGMP requirements. This role will work cross functionally with groups/departments across our site to ensure operational efficiencies and successful production of API. This role will require entering our sterile cleanroom areas while following all relevant gowning, safety, and quality policies. This is an onsite based position Monday-Friday at our bioproduction facility in West Lebanon, NH." That could be About the role. However we also have Responsibilities separate. To avoid duplication, we could put a concise summary
- items.
Now Benefits: we have list from "What We Offer You". Let's extract:
- Leading pay and annual performance bonus for all positions (but we might put pay separately)
- 36 Paid days off including vacation, sick days & company holidays
- Health Insurance, Dental Insurance, Vision Insurance
- Guaranteed 8% 401K contribution plus individual company match option
- 14 weeks Paid Parental Leave
- Free access to Novo Nordisk-marketed pharmaceutical products
- Opportunities, resources and mentorship to grow and build your career.
We could separate Pay: "Leading pay and annual performance bonus for all positions". Benefits: rest.
Schedule: "This is an onsite based position Monday-Friday at our bioproduction facility in West Lebanon, NH." plus "Participate in on-call rotations, including weekends and non-business hours, to provide support." So schedule includes regular Monday-Friday onsite, plus on-call rotations.
Now About the role: maybe we can use the initial paragraph about department/site? Actually "About The Department Site New Hampshire..." is about the site. Could be considered "About the role"? But we already have responsibilities etc. The instruction says use