Project Role : Custom Software Engineer

Project Role Description : Develop custom software solutions to design, code, and enhance components across systems or applications. Use modern frameworks and agile practices to deliver scalable, high-performing solutions tailored to specific business needs.

Must have skills : Manufacturing Engineering MES

Good to have skills : NA
Minimum 3 year(s) of experience is required

Educational Qualification : 15 years full time education

Summary:
We are looking for a Track Trace Specialist with strong experience in design, implement, and support serialization and traceability solutions in pharmaceutical manufacturing. The role focuses on enabling compliant end-to-end product traceability integrated with MES and enterprise systems.

Roles Responsibilities:
Design and implement Track Trace / Serialization (Level 3) solutions
Configure and support serialization processes, including: Commissioning decommissioning Aggregation (bundle, case, pallet) Rework and exception handling
Integrate Track Trace with: SAP ATTP / ICH / S/4HANA Level 2 systems (packaging line controllers like Systech, Optel, etc.) Enterprise reporting systems
Ensure compliance with global regulations: DSCSA, EU FMD, and other country-specific guidelines
Participate in end-to-end deployment and rollout programs across sites
Support CSV validation activities (IQ/OQ/PQ) and documentation




Troubleshoot serialization and MES-related issues in production environments
Collaborate with business, quality, IT, and vendors for solution delivery
Prepare and maintain configurations, design documents, and SOPs

Professional Technical Skills:
3-5 years of experience in Track Trace
Hands-on experience with: Track Trace module
Strong understanding of: Serialization lifecycle and aggregation workflows Integration between Track Trace and SAP ATTP / serialization repositories
Experience in GxP, GMP, and CSV-compliant environments
Exposure to interface technologies (IDoc, APIs, middleware)
Robust debugging and production support skills

Preferred Qualifications
Experience in multi-site Track Trace rollouts
Knowledge of PAS-X 3.x / PAS-X 4 (K rber Werum)
Exposure to packaging line integrations (Level 2/3 systems)
Understanding of pharma supply chain and batch genealogy
Experience working in regulated audit environments
Strong stakeholder management and communication skills
Ability to work with cross-functional and global teams
Analytical mindset with proactive problem-solving
Ability to manage priorities in a delivery-driven environment

- The candidate should have minimum 3 years of experience in Track Trace.

- Bachelor s or Master s in Engineering, Life Sciences, or IT

- This position is based at multiple locations.

- A 15 years full time education is required.

Qualification 15 years full time education

📌 Custom Software Engineer (Pune)
🏢 Accenture
📍 Pune