Validation Engineer I

We need to output HTML fragment with sections: About the role? Actually the posting includes introductory paragraph about Amgen mission, then "VALIDATION ENGINEER I" title (should not repeat as heading). Then "What You Will Do" (responsibilities). Then "What We Expect Of You" (qualifications). Then "What You Can Expect Of Us" (benefits, salary, etc). Also maybe "Pay" and "Schedule" if present. The posting mentions salary range: "The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted." No actual numbers given, just says posted but not provided. Since we cannot include placeholder like "not specified" or "TBD". The rule: never create Pay/Schedule/Benefits sections unless the posting actually states them. It does state that salary range is posted but not give numbers. It's vague. Should we include a Pay section? It says "The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted." That's a statement that salary info exists but not given. Since we don't have actual numbers, we might treat that as not providing concrete info, thus we should not create a Pay section because it would be filler. Similarly benefits: they list benefits in paragraph: "In addition to the base salary, Amgen offers a Total Rewards Plan...". That is substantive benefits info. So we can include Benefits section. Schedule: no mention. Thus sections: About the role? The introductory paragraph about Amgen mission could be considered "About the role" or maybe "About Amgen". The instruction: use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). We need to decide which headings to use based on content. We have: - Intro about Amgen mission and role context: could be "About the role" (or "About Amgen"). - Responsibilities: "What You Will Do" -> Responsibilities. - Qualifications: "What We Expect Of You" -> includes Basic Qualifications, Preferred Qualifications. Could be "Qualifications" or "Requirements". We'll use "Qualifications". - Benefits: "What You Can Expect Of Us" -> Benefits. We should not repeat job title as heading. We need to preserve all substantive information, not invent or summarize away detail. Must keep details. We need to format responsibilities as

• . The responsibilities list is long paragraph with many sentences separated by periods. We need to break into list items. The instruction: Use
  • for any list of duties/requirements/benefits. So we need to convert the responsibilities paragraph into list items. Likely each sentence or clause separated by periods could be a list item. Must preserve all info; we can split at each sentence that starts with a verb. Let's extract responsibilities from "What You Will Do" section. The text after "What You Will Do Let’s do this. Let’s 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 site’s 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 sensible list items. Let's try to break at each sentence that starts with a capital letter after a period. However there are some missing spaces (e.g., "ANCCollaborate"). We'll need to insert spaces where missing for readability but must not invent info. We can keep as is but maybe add a space? The instruction: do not invent or summarize away detail. Adding a space is not inventing info, just formatting. Probably okay. We'll produce list items each starting with a verb. Let's manually parse: 1. 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. Develop and generate documents such as the site’s Validation Master Plan, validation plans, equipment qualification protocols/reports, among others. 3. 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. Work closely with multiple subject areas, including manufacturing, process engineering, process development, utility operations, maintenance, quality assurance, and validation to implement operational improvements. 14. Communicate 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. Provide 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. Now qualifications: "What We Expect Of You We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a person with these qualifications. Basic Qualifications: High school diploma / GED and 8 years of Manufacturing or Operations experience ORAssociate’s degree and 6 years of Manufacturing or Operations experience ORBachelor’s degree and 2 years of Manufacturing or Operations experience ORMaster’s degree Preferred Qualifications: Proficient technical writing and presentations skills to collaborate with technical and senior management staffPosition requires strong written and verbal skills and the ability to work with minimum directionExperience in equipment qualification & cleaning validation (including establishing validation strategies and procedures) for biologics facilityProficiency in Kneat, CDOCs, Laboratory Inventory Management System and PiProven project management experience – ability to manage multiple prioritiesExperience in reviewing/approving validation protocols and reports in support of facility/equipment commissioning, qualification, and change administrationInvolvement in technical implementation of validation tasks associated with cleaning validation, steaming validation (including autoclaves) and controlled temperature chambers (CTC)Knowledge of Regulations Eudralex Annex 15, FDA Title 21 CFR Part 210 and 211, Guidelines ASTM E2500 and ICH Q7Participation in supporting regulatory submissions, response to submission questions, pre-approval/biennial inspections, and observational response plansDemonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment.Ability to apply analytical skills to evaluate and interpret sophisticated problems using multiple sources of information.Ability to function within cross-functional teams and embrace a team-based environment.Experience with Mammalian Cell Culture, Protein Purification, Clean Utilities, CIP, SIP, Production Services, and/or non-GMP Utilities preferredFamiliarity with designing and operating equipment used in biopharmaceutical manufacturing preferred" We need to split into list items for requirements/qualifications. Use
    • . We'll separate Basic Qualifications and Preferred Qualifications maybe as separate subheadings? But instruction only allows headings like About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We could use "Qualifications" heading and inside have two lists: Basic and Preferred. Could also use "Requirements" for Basic and "Skills" for Preferred. But better to follow given examples: they list Qualifications as a possible heading. We'll use

      Qualifications

      and then inside we can have

      Basic Qualifications:

      ... and

      Preferred Qualifications:

      ... That's acceptable. Now Benefits: "What You Can Expect Of Us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. 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 including but not limited to, relevant skills,