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:
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)
Strong 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
Additional Information:
- 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., 15 years full time education
