Job Summary

Lead functional design, implementation, and optimization for ATTP-related programs and initiatives
o Collaborate with business stakeholders & external partners (3PL, CMOs) to gather, analyze, and document functional requirements. Identify AS-IS process and design TO-BE process flows
o Translate business needs into functional specifications and solution designs.
o Act as the primary point of contact between business, IT, and operations teams.
o Define and document how serial number requests, commissioning, packing, shipping, and receiving events flow between the pharmaceutical company (MAH - Marketing Authorization Holder), CMOs, and 3PLs.
o Identify gaps between standard SAP ATTP capabilities and the specific operational capabilities of external partners (e.g., handling partial pallets, aggregations, or returns).
o Ensure the integration design complies with global regulations such as US DSCSA, EU FMD, Etc.
o Configure ATTP repository systems, business partners (CMOs/3PLs), locations (GLNs), and master data (GTINs, SSCCs).
o Design and map standard GS1 EPCIS messages for 3PLs and CMOs.
o Configure ATTP rules, system schemas, and authentication settings to ensure only authorized data exchanges occur with specific partners.
o Collaborate with middleware teams (Dell BOOMI) to establish secure connections (AS2, SFTP, Web Services) with partners.
o Author and distribute Implementation Guidelines (IGs) or Mapping Specifications to CMOs/3PLs, aligning on required EPCIS event fields, business steps, and dispositions.
o Act as the primary technical point of contact to guide external partner IT teams through the testing and onboarding pipeline.
o Conduct End-to-End (E2E) integration testing. This includes simulating automated production runs from CMOs and fulfillment scenarios from 3PLs.
o Author and execute validation deliverables in compliance with GAMP 5 and 21 CFR Part 11, including Functional Specifications (FS), Configuration Specification (CS), and User Acceptance Testing (UAT) scripts.
o Hands-on experience with RISE with SAP
o Ability to perform discovery phase with RISE upgrade and advise on impacts and solution to leadership teams

Key Responsibilities

Lead functional design, implementation, and optimization for ATTP-related programs and initiatives
o Collaborate with business stakeholders & external partners (3PL, CMOs) to gather, analyze, and document functional requirements. Identify AS-IS process and design TO-BE process flows
o Translate business needs into functional specifications and solution designs.
o Act as the primary point of contact between business, IT, and operations teams.
o Define and document how serial number requests, commissioning, packing, shipping, and receiving events flow between the pharmaceutical company (MAH - Marketing Authorization Holder), CMOs, and 3PLs.
o Identify gaps between standard SAP ATTP capabilities and the specific operational capabilities of external partners (e.g., handling partial pallets, aggregations, or returns).
o Ensure the integration design complies with global regulations such as US DSCSA, EU FMD, Etc.
o Configure ATTP repository systems, business partners (CMOs/3PLs), locations (GLNs), and master data (GTINs, SSCCs).
o Design and map standard GS1 EPCIS messages for 3PLs and CMOs.
o Configure ATTP rules, system schemas, and authentication settings to ensure only authorized data exchanges occur with specific partners.
o Collaborate with middleware teams (Dell BOOMI) to establish secure connections (AS2, SFTP, Web Services) with partners.
o Author and distribute Implementation Guidelines (IGs) or Mapping Specifications to CMOs/3PLs, aligning on required EPCIS event fields, business steps, and dispositions.
o Act as the primary technical point of contact to guide external partner IT teams through the testing and onboarding pipeline.
o Conduct End-to-End (E2E) integration testing. This includes simulating automated production runs from CMOs and fulfillment scenarios from 3PLs.
o Author and execute validation deliverables in compliance with GAMP 5 and 21 CFR Part 11, including Functional Specifications (FS), Configuration Specification (CS), and User Acceptance Testing (UAT) scripts.
o Hands-on experience with RISE with SAP
o Ability to perform discovery phase with RISE upgrade and advise on impacts and solution to leadership teams

Skill Requirements

Other Requirements