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
2 year(s) of experience is required
Educational Qualification : 15 years full time education
Summary:
We are seeking a TraceLink Track & Trace Specialist with expertise in serialization and pharma supply chain integration to implement and support TraceLink solutions. The role focuses on enabling regulatory compliance and seamless connectivity across partners, contract manufacturers, and enterprise systems.
Roles & Responsibilities:
Configure and support TraceLink serialization platform (Level 4/5)
Implement and manage serialization reporting and partner connectivity (CMOs, distributors, regulators)
Integrate TraceLink with:
o SAP ATTP / S/4HANA / ECC
o MES / Level 3 systems (PAS-X, PharmaSuite, etc.)
o External trading partners via TraceLink network
Support regulatory compliance including:
o DSCSA (US), EU FMD, and other global mandates
Manage EPCIS data exchange, verification, and reconciliation processes
Support onboarding of new partners and manage B2B integrations
Participate in serialization rollout programs and system enhancements
Troubleshoot production and partner connectivity issues
Support CSV validation (IQ/OQ/PQ) and maintain compliance documentation
Collaborate with supply chain, IT, quality, and external stakeholders
Preferred Qualifications
Experience in multi-country serialization rollouts
Familiarity with TraceLink modules (e.g., Serialized Operations Manager, Compliance Manager)
Experience working with CMOs and external supply chain partners
Exposure to API/middleware-based integrations
Understanding of pharma supply chain and distribution
Strong stakeholder and partner communication skills
Ability to coordinate across global teams and external organizations
Proactive problem-solving and ownership mindset
Ability to work in a fast-paced, compliance-driven environment
Professional & Technical Skills:
2-4 years of experience in Track & Trace / Serialization in pharma
Hands-on experience with:
o TraceLink platform (serialization, network connectivity, reporting)
Strong understanding of:
o Serialization lifecycle and EPCIS standards
o Partner onboarding and B2B integration workflows
Experience integrating with SAP ATTP / MES / L3 systems
Knowledge of GxP, GMP, and validation processes
Strong analytical and troubleshooting skills
Additional Information:
- The candidate should have minimum 2 years of experience in TraceLink Track & Trace.
- Bachelor s or Master s degree in Engineering, IT, Life Sciences, or related field
- This position is based at multiple office.
- A 15 years full time education is required.