Serialization System Engineer

3 days ago


Chennai, Tamil Nadu, India beBeeSerialization Full time ₹ 9,00,000 - ₹ 12,00,000
Job Title:
Serialization Systems Manager

  • Manage the implementation, operation, and maintenance of serialization systems in pharmaceutical packaging lines.
  • Develop and execute strategies to ensure compliance with global regulatory standards such as DSCSA (US) and EU FMD.

Experience & Skills

  • Bachelor's degree in Engineering, Life Sciences, or related field.
  • ~7+ years of experience in pharmaceutical serialization or packaging automation.
  • Hands-on experience with serialization systems and regulatory compliance.

System Management

  • Manage databases and digital fingerprinting systems such as Guardian Digital Fingerprint , Guardian UniSecure , and Guardian UniTrace .
  • Oversee integration of serialization software with packaging equipment and ERP systems.

Compliance & Regulatory

  • Maintain audit readiness and support internal/external inspections.

Technical Support & Troubleshooting

  • Provide hands-on support for serialization and vision inspection systems.
  • Lead root cause analysis (RCA) and implement corrective/preventive actions (CAPA).

Project Execution

  • Lead serialization-related projects including system upgrades, new line implementations, and artwork changes.
  • Coordinate with cross-functional teams including QA, packaging, supply chain, and regulatory affairs.

Training & Documentation

  • Develop and deliver training programs for operators and maintenance staff.
  • Maintain detailed records of system configurations, incidents, and resolutions.

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