Validation Engineer I
for section headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to parse the posting.
We need to remove boilerplate: cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate, duplicated lines, application instructions. Also remove "Join Amgens Mission of Serving Patients" etc? That is about the role? Actually the first paragraph is about Amgen mission. That could be "About the role" or maybe "About the company". The instruction: Use for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we need to decide which sections to include based on content.
We have:
- Intro about Amgen mission: could be "About the role" or maybe "About Amgen". But they said "About the role" as example. We can treat that as "About the role". It contains description of mission, therapeutic areas, pipeline, culture. That's substantive.
- Then "VALIDATION ENGINEER I" is the job title; we should not repeat as heading.
- Then "What You Will Do" is responsibilities. So we need a Responsibilities section with bullet list of duties.
- Then "What we expect of you" includes qualifications: Basic Qualifications and Preferred Qualifications. Could be split into Requirements and Qualifications? The instruction: Use headings like Requirements, Qualifications, Skills. We need to decide.
We have Basic Qualifications (education + experience) and Preferred Qualifications (skills, experience). Could treat Basic as Requirements, Preferred as Qualifications or Skills. Also there is a list of technical skills etc.
- Then "What you can expect of us" includes benefits, salary range, total rewards. So we can have Benefits section (maybe also Pay). They said include Pay section only if posting actually states them. The posting says: "The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors..." It does not give actual numbers, just says range is posted (but not provided). Since no specific numbers, we should not create Pay section because it's not specific. The instruction: 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. Benefits: they list benefits: "In Addition To The Base Salary, Amgen Offers a Total Rewards Plan, Based On Eligibility, Comprising Of Health And Welfare Plans For Staff And Eligible Dependents, Financial Plans With Opportunities To Save Towards Retirement Or Other Goals, Work/life Balance, And Career Development Opportunities That May Include A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models where possible." That's specific benefits. So we can include Benefits section.
Schedule: not mentioned. So no Schedule.
We also need to remove duplicated lines, boilerplate like EEO, accommodation, sponsorship, etc. Also remove "Apply now and make a lasting impact with the Amgen team.careers.amgen.com" etc. Also remove "In any materials you submit, you may redact..." etc. Also remove "Application deadline Amgen does not have an application deadline..." etc. Also remove "Sponsorship Sponsorship for this role is not guaranteed." etc. Also remove EEO statement.
We need to preserve all substantive information. So we need to keep the mission description, responsibilities list, basic qualifications, preferred qualifications, benefits description.
We need to format responsibilities as - . Also qualifications as list.
We need to decide headings: About the role (intro), Responsibilities, Requirements (basic qualifications), Qualifications (preferred qualifications), Benefits.
We could also include Skills as separate but we can merge into Qualifications.
Let's extract content.
Intro (About the role):
"Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career."
We need to clean up spacing and punctuation: there are missing spaces. We'll keep as is but maybe fix obvious missing spaces: "Amgens Mission" -> "Amgen's Mission". But we should not invent? The instruction: preserve ALL substantive information; do NOT invent or summarize away detail. Should we correct typos? It's ambiguous. Probably we should keep the text exactly as given, but we can fix obvious missing spaces? That might be considered inventing? Safer to keep as is. However the text has missing spaces after "Amgens Mission of Serving Patients At Amgen". We could keep it exactly; it's still substantive. We'll not add punctuation.
But we need to output HTML; we can keep the text inside
.
Now Responsibilities: The bullet points after "What You Will Do Lets do this. Lets change the world. In this vital role you will serve as a technical lead/subject matter expert (SME) and lead the development and implementation of the Validation strategy at the Amgen North Carolina (ANC) manufacturing facility. Specifically, this role has responsibility for developing and generating documents such as the sites Validation Master Plan, validation plans, equipment qualification protocols/reports, among others. In addition, the position will be accountable for completing landmarks related to results for autoclave performance qualification, cleaning validation, and validation maintenance. Provide technical support and domain expertise for commissioning, qualification, cleaning/sterilization validation, and validation maintenance activities in ANCCollaborate with project leads with direct accountability for project results related to validation outputs for commissioning and qualification of manufacturing process equipmentSupply cleaning/sterilization validation expertise including generation/review/approval of cleaning related documents (e.g., cleaning characterization/inactivation reports, acceptance limits reports)Coordinate actions with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure that the overall Amgen validation requirements are metFurnish technical assistance and represent validation for regulatory filings, audits, and inspectionsEnsure maintenance of site validation master plan and routine monitoring of validation status/regulatory compliance of equipment and systemsSupport site/network validation driven continuous improvement initiativesDevelop, coordinate, analyze, and present results for operational issues and engineering projectsProvide technical support to commercial and clinical manufacturing as needed, specific to process control and process equipment.Working closely with multiple subject areas, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvementsCommunicating with supervisor and support staff, highlighting issues and proposing solutions.Work in a small group of engineers and/or technicians on an ongoing or project basis.Provide technical support and issue resolution with 24x7 on-call support of process systems on a rotational based frequency.Conduct PQs for parts washers and autoclavesCreate / update cleaning process SOPs and / or work instructionsWork independently with internal and external stakeholders.Support the development of the periodic cleaning monitoring programProvide engineering support for design, construction, startup, commissioning and qualification.Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity.Ensure necessary commissioning and qualification of systems is completed in alignment with site GMP requirements and interact with regulatory inspectors as necessary.Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant and process systems.Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. (Support may be required outside of normal working hours including nights, weekends and holidays)Support investigations of abnormal conditions through Deviation and business processes"
We need to split into list items. The text is a run-on; we need to parse logical sentences separated by periods. We'll split at periods and create
- items. Ensure we keep all content.
Let's manually extract sentences:
1. In this vital role you will serve as a technical lead/subject matter expert (SME) and lead the development and implementation of the Validation strategy at the Amgen North Carolina (ANC) manufacturing facility.
2. Specifically, this role has responsibility for developing and generating documents such as the sites Validation Master Plan, validation plans, equipment qualification protocols/reports, among others.
3. In addition, the position will be accountable for completing landmarks related to results for autoclave performance qualification, cleaning validation, and validation maintenance.
4. Provide technical support and domain expertise for commissioning, qualification, cleaning/sterilization validation, and validation maintenance activities in ANC
5. Collaborate with project leads with direct accountability for project results related to validation outputs for commissioning and qualification of manufacturing process equipment
6. Supply cleaning/sterilization validation expertise including generation/review/approval of cleaning related documents (e.g., cleaning characterization/inactivation reports, acceptance limits reports)
7. Coordinate actions with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure that the overall Amgen validation requirements are met
8. Furnish technical assistance and represent validation for regulatory filings, audits, and inspections
9. Ensure maintenance of site validation master plan and routine monitoring of validation status/regulatory compliance of equipment and systems
10. Support site/network validation driven continuous improvement initiatives
11. Develop, coordinate, analyze, and present results for operational issues and engineering projects
12. Provide technical support to commercial and clinical manufacturing as needed, specific to process control and process equipment.
13. Working closely with multiple subject areas, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements
14. Communicating with supervisor and support staff, highlighting issues and proposing solutions.
15. Work in a small group of engineers and/or technicians on an ongoing or project basis.
16. Provide technical support and issue resolution with 24x7 on-call support of process systems on a rotational based frequency.
17. Conduct PQs for parts washers and autoclaves
18. Create / update cleaning process SOPs and / or work instructions
19. Work independently with internal and external stakeholders.
20. Support the development of the periodic cleaning monitoring program
21. Provide engineering support for design, construction, startup, commissioning and qualification.
22. Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity.
23. Ensure necessary commissioning and qualification of systems is completed in alignment with site GMP requirements and interact with regulatory inspectors as necessary.
24. Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant and process systems.
25. Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. (Support may be required outside of normal working hours including nights, weekends and holidays)
26. Support investigations of abnormal conditions through Deviation and business processes
Note: Some sentences have weird capitalization; we keep as
- . Also qualifications as list.
We need to decide headings: About the role (intro), Responsibilities, Requirements (basic qualifications), Qualifications (preferred qualifications), Benefits.
We could also include Skills as separate but we can merge into Qualifications.
Let's extract content.
Intro (About the role):
"Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career."
We need to clean up spacing and punctuation: there are missing spaces. We'll keep as is but maybe fix obvious missing spaces: "Amgens Mission" -> "Amgen's Mission". But we should not invent? The instruction: preserve ALL substantive information; do NOT invent or summarize away detail. Should we correct typos? It's ambiguous. Probably we should keep the text exactly as given, but we can fix obvious missing spaces? That might be considered inventing? Safer to keep as is. However the text has missing spaces after "Amgens Mission of Serving Patients At Amgen". We could keep it exactly; it's still substantive. We'll not add punctuation.
But we need to output HTML; we can keep the text inside
. Now Responsibilities: The bullet points after "What You Will Do Lets do this. Lets change the world. In this vital role you will serve as a technical lead/subject matter expert (SME) and lead the development and implementation of the Validation strategy at the Amgen North Carolina (ANC) manufacturing facility. Specifically, this role has responsibility for developing and generating documents such as the sites Validation Master Plan, validation plans, equipment qualification protocols/reports, among others. In addition, the position will be accountable for completing landmarks related to results for autoclave performance qualification, cleaning validation, and validation maintenance. Provide technical support and domain expertise for commissioning, qualification, cleaning/sterilization validation, and validation maintenance activities in ANCCollaborate with project leads with direct accountability for project results related to validation outputs for commissioning and qualification of manufacturing process equipmentSupply cleaning/sterilization validation expertise including generation/review/approval of cleaning related documents (e.g., cleaning characterization/inactivation reports, acceptance limits reports)Coordinate actions with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure that the overall Amgen validation requirements are metFurnish technical assistance and represent validation for regulatory filings, audits, and inspectionsEnsure maintenance of site validation master plan and routine monitoring of validation status/regulatory compliance of equipment and systemsSupport site/network validation driven continuous improvement initiativesDevelop, coordinate, analyze, and present results for operational issues and engineering projectsProvide technical support to commercial and clinical manufacturing as needed, specific to process control and process equipment.Working closely with multiple subject areas, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvementsCommunicating with supervisor and support staff, highlighting issues and proposing solutions.Work in a small group of engineers and/or technicians on an ongoing or project basis.Provide technical support and issue resolution with 24x7 on-call support of process systems on a rotational based frequency.Conduct PQs for parts washers and autoclavesCreate / update cleaning process SOPs and / or work instructionsWork independently with internal and external stakeholders.Support the development of the periodic cleaning monitoring programProvide engineering support for design, construction, startup, commissioning and qualification.Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity.Ensure necessary commissioning and qualification of systems is completed in alignment with site GMP requirements and interact with regulatory inspectors as necessary.Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant and process systems.Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. (Support may be required outside of normal working hours including nights, weekends and holidays)Support investigations of abnormal conditions through Deviation and business processes" We need to split into list items. The text is a run-on; we need to parse logical sentences separated by periods. We'll split at periods and create
- items. Ensure we keep all content. Let's manually extract sentences: 1. In this vital role you will serve as a technical lead/subject matter expert (SME) and lead the development and implementation of the Validation strategy at the Amgen North Carolina (ANC) manufacturing facility. 2. Specifically, this role has responsibility for developing and generating documents such as the sites Validation Master Plan, validation plans, equipment qualification protocols/reports, among others. 3. In addition, the position will be accountable for completing landmarks related to results for autoclave performance qualification, cleaning validation, and validation maintenance. 4. Provide technical support and domain expertise for commissioning, qualification, cleaning/sterilization validation, and validation maintenance activities in ANC 5. Collaborate with project leads with direct accountability for project results related to validation outputs for commissioning and qualification of manufacturing process equipment 6. Supply cleaning/sterilization validation expertise including generation/review/approval of cleaning related documents (e.g., cleaning characterization/inactivation reports, acceptance limits reports) 7. Coordinate actions with Manufacturing, Engineering, Quality, Supply Chain, and Process Development to ensure that the overall Amgen validation requirements are met 8. Furnish technical assistance and represent validation for regulatory filings, audits, and inspections 9. Ensure maintenance of site validation master plan and routine monitoring of validation status/regulatory compliance of equipment and systems 10. Support site/network validation driven continuous improvement initiatives 11. Develop, coordinate, analyze, and present results for operational issues and engineering projects 12. Provide technical support to commercial and clinical manufacturing as needed, specific to process control and process equipment. 13. Working closely with multiple subject areas, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements 14. Communicating with supervisor and support staff, highlighting issues and proposing solutions. 15. Work in a small group of engineers and/or technicians on an ongoing or project basis. 16. Provide technical support and issue resolution with 24x7 on-call support of process systems on a rotational based frequency. 17. Conduct PQs for parts washers and autoclaves 18. Create / update cleaning process SOPs and / or work instructions 19. Work independently with internal and external stakeholders. 20. Support the development of the periodic cleaning monitoring program 21. Provide engineering support for design, construction, startup, commissioning and qualification. 22. Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity. 23. Ensure necessary commissioning and qualification of systems is completed in alignment with site GMP requirements and interact with regulatory inspectors as necessary. 24. Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant and process systems. 25. Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. (Support may be required outside of normal working hours including nights, weekends and holidays) 26. Support investigations of abnormal conditions through Deviation and business processes Note: Some sentences have weird capitalization; we keep as