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In this vital role you will be responsible for designing, configuring, and integrating SAP QM processes within S/4HANA across all the Amgen manufacturing and distribution sites. This role focuses on leveraging SAP technologies to streamline and enhance QM processes, ensuring alignment with business needs and industry best practices. As an Sr Associate SAP Architect , you will work closely with operations IT and business stakeholders in Manufacturing, Supply Chain and Procurement to ensure quality processes are seamlessly integrated and compliant with regulatory standards. This position requires deep expertise in SAP S/4 HANA QM & PP-PI modules with cross-functional collaboration with MM, SD, EWM and EAM modules to optimize quality inspection, notification and audit processes.
Job Responsibility:
Design, configuration, and implementation of SAP S/4HANA Quality Management processes
Design, configuration, and implementation of SAP S/4HANA PP-PI module aligned with life sciences manufacturing best practices
Translate business requirements into SAP QM functional specifications aligned with life sciences regulatory needs (GxP, GMP, FDA 21 CFR Part 11, ISO 9001)
Configure inspection planning, results recording, usage decisions, and quality notifications
Support integration with related modules including MM (Procurement), PP (Production), PM (Maintenance), and EWM (Warehouse Management)
Conduct architectural reviews and assessments to identify potential risks and recommend mitigation strategies
Creation and maintenance of critical documentation such as technical assessments, configuration specs, functional designs, test cases, and user manuals
Ensure compliance with pharmaceutical industry standards and regulations
Participate in sprint planning, reviews, and retrospectives to deliver and sustain Amgen's S/4HANA ecosystem utilizing the Scaled Agile Framework (SAFe)
Develop innovative solutions that drive speed to value via AI/ML and leading practices
Requirements:
Master’s degree with 1 to 3 years of SAP implementation experience in SAP S/4HANA Quality Management & Production & Planning modules
Bachelor’s degree with 3 to 5 years of SAP implementation experience in SAP S/4HANA Quality Management & Production & Planning modules
Diploma with 7 to 9 years of IT or years of SAP implementation experience in SAP S/4HANA Quality Management & Production & Planning modules
Strong Hands-on in end-to-end QM processes: inspection planning, notifications, batch management, and audit handling
Strong Hands-on in production & planning, master data, Material masters, BOM, Resource, Recipe, production version, Demand management, MRP, process orders etc.
Experience in regulated environments (Life Sciences, Biotech, or pharmaceutical industry)
Deep understanding of GxP, GMP, and FDA 21 CFR Part 11 requirements
Experience working in multi-site or global SAP S/4 rollouts
Ability to design and implement solutions based on business requirements, including debugging and root cause analysis
Experience in creating detailed documentation, including functional specifications, test cases, and compliance reports
SAP Certified Application Associate in SAP S/4HANA QM & PP-PI modules
Agile Certified Practitioner (preferred)
Strong analytical and problem-solving abilities
Excellent communication and collaboration skills
Ability to work effectively with cross-functional teams and stakeholders
Detail-oriented with a focus on accuracy and compliance
This position requires you to work a later shift and may be assigned a second shift schedule
Candidates must be willing and able to work during evening shift, as required based on business requirements
Nice to have:
Knowledge of Batch release hub
Knowledge of SAP S/4HANA MM and SD processes
Integration experience with SAP EWM, LIMS, MES and other non-SAP systems
Familiarity with Agile methodologies for software delivery and process improvement
What we offer:
Reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment