Sr Associate SAP Architect

Biopharma Careers; Hyderabad; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Amgen in India seeks a Sr Associate SAP Architect to design, configure, and integrate SAP S/4HANA QM & PP-PI across manufacturing and distribution sites, aligning with GxP, GMP and FDA 21 CFR Part 11 requirements.

You will collaborate with Operations IT, Manufacturing, Supply Chain and Procurement to ensure quality processes are integrated and compliant, delivering scalable solutions with SAFe agile practices and exploring AI/ML opportunities.

Qualifications

• Strong hands-on in end-to-end QM processes and integration with related SAP modules.
• Experience in regulated environments (Life Sciences or pharmaceutical industry).
• Understanding of GxP, GMP, and FDA 21 CFR Part 11 requirements.

Responsibilities

• 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.
• Translate business requirements into functional specifications compliant with life sciences regulatory needs.
• Configure inspection planning, results recording, usage decisions, and quality notifications.
• Collaborate with MM, SD, EWM, and EAM modules to optimize quality processes.

Job description

Career Category

Manufacturing

Job Description

ABOUT AMGEN

Amgen harnesses the best of biology and technology to fight the world’s toughest diseases, and make people’s lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what’s known today.

ROLE DESCRIPTION : ROLES & RESPONSIBILITIES.

• Let’s do this. Let’s change the world. 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.
• 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

FUNCTIONAL SKILLS : MUST-HAVE-SKILLS

• Strong Hands-on in end-to-end QM processes: inspection planning, notifications, batch management, and audit handling. Integration experience with SAP EWM, LIMS, MES and other non-SAP systems
• 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.

NICE-TO-HAVE-SKILLS

• 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.

PROFESSIONAL CERTIFICATIONS

• SAP Certified Application Associate in SAP S/4HANA QM & PP-PI modules.
• Agile Certified Practitioner (preferred)

SOFT SKILLS

• 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.

BASIC QUALIFICATIONS & EXPERIENCE

Master’s degree with 1 to 3 years of SAP implementation experience in SAP S/4HANA Quality Management & Production & Planning modules OR

Bachelor’s degree with 3 to 5 years of SAP implementation experience in SAP S/4HANA Quality Management & Production & Planning modules OR

Diploma with 7 to 9 years of IT or years of SAP implementation experience in SAP S/4HANA Quality Management & Production & Planning modules.

SHIFT INFORMATION

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.

EQUAL OPPORTUNITY STATEMENT

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided with 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. Please contact us to request accommodation.