Principal Track and Trace Technical Engineer Architect
Job Summary
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Job Description
This is the correct JD for the required position:
Engineer Level V Principal Track and Trace Technical Engineer / Architect
Position Summary
The Principal Track and Trace Technical Engineer V acts as an enterprise expert on Track and Trace (T&T)/serialization with strong preference in SAP ATTP SAP ICH TraceLink architecting global solutions and driving strategy across multiple business units. This position is responsible for the most complex challenges in serialization innovation and regulatory alignment while providing strategic leadership and mentorship.
Key Responsibilities
- Serve as the global architect and technical authority for SAP ATTP TraceLink and SAP ICH and pharma serialization solutions. Knowledge of ABAP (SAP coding language) a plus.
- Expertise in design development testing deploying and documenting T&T solutions under GxP environment
- Define and drive the strategic direction for serialization technologies and compliance across the organization.
- Document technical issues solutions and standard procedures knowledge of validation tools such as ServiceNow and/or ALM tools and/or Veeva needed.
- Experience in product life cycle management process.
- Identify and implement innovations to enhance system reliability scalability and compliance.
- Lead the design and governance of interfaces and integrations (e.g. SAP ECC MDMD ATTP MES). Knowledge of packaging line platforms L1 to L3 (Systech/Guardian) and its integration with upper system L4-L5.
- Oversee the end-to-end security and data integrity for serialization transactions worldwide.
- Advise executive management and global partners on emerging regulatory trends and technology evolution.
- Lead crisis management and critical incident resolution at a global scale. Anticipate identify and communicate risk with an ability to propose mitigation plans.
- Manage vendor relationships contract negotiations and large-scale project portfolios.
- Champion best practices continuous improvement and cross-functional knowledge sharing.
Requirements
- Masters degree (preferred) or Bachelors in Computer Science IT Engineering or relevant field.
- 8 years experience in life sciences IT with deep hands-on specialization in serialization and track & trace.
- Expertise in SAP ATTP SAP ICH TraceLink design deployment customization and global governance. Knowledge of T&T middleware solutions a plus.
- Experience in a regulated environment (GxP 21 CFR Part 11 etc.). Experience with standard IT tools used in GxP environment including (but not limited) to Veeva ServiceNow ALM considered as a plus.
- Demonstrated leadership in architecting and delivering global serialization solutions.
- Comprehensive understanding of global pharmaceutical regulatory environments (e.g. US DSCSA EU FMD specific country regulations etc.).
- Strong project management stakeholder engagement and executive presentation skills.
- Recognized authority within the Track and Trace team able to influence direction within T&T decisions and regulatory dialogue.
- Strong written and verbal communication skills with an ability to communicate complex technical matters in clear simple and concise English terms.
Locations
IND - BengaluruWorker Type
EmployeeWorker Sub-Type
RegularTime Type
Full timeRequired Experience:
Staff IC
About Company
Takeda is a patient-focused, R&D-driven global biopharmaceutical company committed to bringing Better Health and a Brighter Future.