SAP Validation Functional Analyst
Amgen
SAP Validation Functional Analyst
Job Description
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.
What you will do
- Execute validation deliverables for SAP ERP systems (ECC, S/4HANA, BTP, GRC, and related platforms) in alignment with Amgen’s procedures and regulatory expectations.
- Support the creation, execution, and review of validation documentation (e.g., Validation Plan, Requirements, IQ, OQ, PQ/UAT test scripts, Traceability Matrix, Validation Report).
- Collaborate with project teams, quality assurance, and business stakeholders to ensure requirements are clearly defined and properly tested.
- Assist in maintaining operational compliance for SAP systems, including activities related to Incident Management, Problem Management, Change Control, CAPA, and Deviation tracking.
- Participate in periodic reviews, user access reviews (UARs), and audit trail checks to maintain ongoing compliance.
- Contribute to audit readiness by supporting evidence collection and responding to inspection requests.
- Stay current with evolving GxP regulations, guidelines (21 CFR Part 11, Annex 11, GAMP 5), and Amgen’s IT-QMS.
- Explore opportunities to leverage digital validation and automation tools to improve efficiency.
What we expect of you
- Any degree and 5-9 years of Computer Science, IT or related field experience OR Extensive SAP Validation Experience: Minimum of 2 years in validating SAP systems in a regulated environment.
- Documentation Proficiency: Expertise in creating and managing Risk based validation documentation including Validation Plan, Specifications, IQ, OQ, PQ/UAT, RTM and Validation Report.
- Regulatory Compliance Knowledge: In-depth understanding of GxP regulations.
- Preferred: Experience with validation or ITSM tools (e.g., ServiceNow, Veeva CDOCs, ALM, JIRA).
- Preferred: Exposure to Agile or SAFe methodologies for IT delivery.
- Preferred: SAP or quality-related certifications.
- Preferred: Professional Certifications: Scrum Master (preferred), SAP certification (preferred).
Must-Have Skills
- Strong capability to analyze complex issues and develop effective solutions.
- Excellent verbal and written communication skills for collaborator interactions and documentation.
- High degree of precision in managing validation documentation and ensuring regulatory compliance.
- Ability to manage changing requirements and priorities effectively.
- Ability to focus on team collaboration and achieving project goals.
What you can expect of us
- Competitive benefits
- Collaborative culture
- Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
Compensation
5-9
Locations
- Hyderabad, India
Salary
Salary not disclosed
Estimated Salary Rangehigh confidence
15,000 - 25,000 USD / yearly
Source: xAI estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong capability to analyze complex issues and develop effective solutions.intermediate
- Excellent verbal and written communication skills for collaborator interactions and documentation.intermediate
- High degree of precision in managing validation documentation and ensuring regulatory compliance.intermediate
- Ability to manage changing requirements and priorities effectively.intermediate
- Ability to focus on team collaboration and achieving project goals.intermediate
Required Qualifications
- Any degree and 5-9 years of Computer Science, IT or related field experience OR Extensive SAP Validation Experience: Minimum of 2 years in validating SAP systems in a regulated environment. (experience)
- Documentation Proficiency: Expertise in creating and managing Risk based validation documentation including Validation Plan, Specifications, IQ, OQ, PQ/UAT, RTM and Validation Report. (experience)
- Regulatory Compliance Knowledge: In-depth understanding of GxP regulations. (experience)
- Preferred: Experience with validation or ITSM tools (e.g., ServiceNow, Veeva CDOCs, ALM, JIRA). (experience)
- Preferred: Exposure to Agile or SAFe methodologies for IT delivery. (experience)
- Preferred: SAP or quality-related certifications. (experience)
- Preferred: Professional Certifications: Scrum Master (preferred), SAP certification (preferred). (experience)
Responsibilities
- Execute validation deliverables for SAP ERP systems (ECC, S/4HANA, BTP, GRC, and related platforms) in alignment with Amgen’s procedures and regulatory expectations.
- Support the creation, execution, and review of validation documentation (e.g., Validation Plan, Requirements, IQ, OQ, PQ/UAT test scripts, Traceability Matrix, Validation Report).
- Collaborate with project teams, quality assurance, and business stakeholders to ensure requirements are clearly defined and properly tested.
- Assist in maintaining operational compliance for SAP systems, including activities related to Incident Management, Problem Management, Change Control, CAPA, and Deviation tracking.
- Participate in periodic reviews, user access reviews (UARs), and audit trail checks to maintain ongoing compliance.
- Contribute to audit readiness by supporting evidence collection and responding to inspection requests.
- Stay current with evolving GxP regulations, guidelines (21 CFR Part 11, Annex 11, GAMP 5), and Amgen’s IT-QMS.
- Explore opportunities to leverage digital validation and automation tools to improve efficiency.
Benefits
- general: Competitive benefits
- general: Collaborative culture
- general: Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
Tags & Categories
SAP Validation Functional Analyst
Amgen
SAP Validation Functional Analyst
Job Description
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do.
What you will do
- Execute validation deliverables for SAP ERP systems (ECC, S/4HANA, BTP, GRC, and related platforms) in alignment with Amgen’s procedures and regulatory expectations.
- Support the creation, execution, and review of validation documentation (e.g., Validation Plan, Requirements, IQ, OQ, PQ/UAT test scripts, Traceability Matrix, Validation Report).
- Collaborate with project teams, quality assurance, and business stakeholders to ensure requirements are clearly defined and properly tested.
- Assist in maintaining operational compliance for SAP systems, including activities related to Incident Management, Problem Management, Change Control, CAPA, and Deviation tracking.
- Participate in periodic reviews, user access reviews (UARs), and audit trail checks to maintain ongoing compliance.
- Contribute to audit readiness by supporting evidence collection and responding to inspection requests.
- Stay current with evolving GxP regulations, guidelines (21 CFR Part 11, Annex 11, GAMP 5), and Amgen’s IT-QMS.
- Explore opportunities to leverage digital validation and automation tools to improve efficiency.
What we expect of you
- Any degree and 5-9 years of Computer Science, IT or related field experience OR Extensive SAP Validation Experience: Minimum of 2 years in validating SAP systems in a regulated environment.
- Documentation Proficiency: Expertise in creating and managing Risk based validation documentation including Validation Plan, Specifications, IQ, OQ, PQ/UAT, RTM and Validation Report.
- Regulatory Compliance Knowledge: In-depth understanding of GxP regulations.
- Preferred: Experience with validation or ITSM tools (e.g., ServiceNow, Veeva CDOCs, ALM, JIRA).
- Preferred: Exposure to Agile or SAFe methodologies for IT delivery.
- Preferred: SAP or quality-related certifications.
- Preferred: Professional Certifications: Scrum Master (preferred), SAP certification (preferred).
Must-Have Skills
- Strong capability to analyze complex issues and develop effective solutions.
- Excellent verbal and written communication skills for collaborator interactions and documentation.
- High degree of precision in managing validation documentation and ensuring regulatory compliance.
- Ability to manage changing requirements and priorities effectively.
- Ability to focus on team collaboration and achieving project goals.
What you can expect of us
- Competitive benefits
- Collaborative culture
- Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
Compensation
5-9
Locations
- Hyderabad, India
Salary
Salary not disclosed
Estimated Salary Rangehigh confidence
15,000 - 25,000 USD / yearly
Source: xAI estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Strong capability to analyze complex issues and develop effective solutions.intermediate
- Excellent verbal and written communication skills for collaborator interactions and documentation.intermediate
- High degree of precision in managing validation documentation and ensuring regulatory compliance.intermediate
- Ability to manage changing requirements and priorities effectively.intermediate
- Ability to focus on team collaboration and achieving project goals.intermediate
Required Qualifications
- Any degree and 5-9 years of Computer Science, IT or related field experience OR Extensive SAP Validation Experience: Minimum of 2 years in validating SAP systems in a regulated environment. (experience)
- Documentation Proficiency: Expertise in creating and managing Risk based validation documentation including Validation Plan, Specifications, IQ, OQ, PQ/UAT, RTM and Validation Report. (experience)
- Regulatory Compliance Knowledge: In-depth understanding of GxP regulations. (experience)
- Preferred: Experience with validation or ITSM tools (e.g., ServiceNow, Veeva CDOCs, ALM, JIRA). (experience)
- Preferred: Exposure to Agile or SAFe methodologies for IT delivery. (experience)
- Preferred: SAP or quality-related certifications. (experience)
- Preferred: Professional Certifications: Scrum Master (preferred), SAP certification (preferred). (experience)
Responsibilities
- Execute validation deliverables for SAP ERP systems (ECC, S/4HANA, BTP, GRC, and related platforms) in alignment with Amgen’s procedures and regulatory expectations.
- Support the creation, execution, and review of validation documentation (e.g., Validation Plan, Requirements, IQ, OQ, PQ/UAT test scripts, Traceability Matrix, Validation Report).
- Collaborate with project teams, quality assurance, and business stakeholders to ensure requirements are clearly defined and properly tested.
- Assist in maintaining operational compliance for SAP systems, including activities related to Incident Management, Problem Management, Change Control, CAPA, and Deviation tracking.
- Participate in periodic reviews, user access reviews (UARs), and audit trail checks to maintain ongoing compliance.
- Contribute to audit readiness by supporting evidence collection and responding to inspection requests.
- Stay current with evolving GxP regulations, guidelines (21 CFR Part 11, Annex 11, GAMP 5), and Amgen’s IT-QMS.
- Explore opportunities to leverage digital validation and automation tools to improve efficiency.
Benefits
- general: Competitive benefits
- general: Collaborative culture
- general: Competitive and comprehensive Total Rewards Plans that are aligned with local industry standards
Tags & Categories