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Serialization Engineer

2 months ago

Duluth, Georgia, United States Validation & Engineering Group Full time
Job Title: Serialization Engineer

We are seeking a highly skilled Serialization Engineer to join our team at Validation & Engineering Group USA, Inc. (V&EG USA). As a leading services supplier, we provide solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries.

Key Responsibilities:

  • Develop and implement serialization systems in packaging lines using Optel technology.
  • Manage the tracing of production and/or packaging data to ensure accuracy and compliance throughout the entire process.
  • Ensure accurate and timely transfer of serialization information, supporting compliance needs and maintaining data integrity.
  • Address and overcome serialization challenges such as label redesign, integration with enterprise software, and maintaining efficiency during implementation.
  • Provide technical support and troubleshooting for serialization equipment and software, ensuring seamless operation and compliance.
  • Collaborate with cross-functional teams to integrate and optimize serialization systems.
  • Participate in the validation of serialization systems and equipment, adhering to industry standards and regulatory requirements.
  • Document processes and maintain accurate records of serialization configurations, changes, and data transfer activities.

Qualifications:

  • Bachelor's degree in Engineering, Computer Science, or a related field.
  • Minimum 5 years of experience in pharmaceutical serialization and packaging, with a proven track record of working with Optel's serialization solutions.
  • Proficiency in software coding related to packaging systems and serialization.
  • In-depth knowledge of serialization challenges and compliance with regulations related to data integrity.
  • Strong problem-solving skills and attention to detail.
  • Ability to work collaboratively in a fast-paced environment and adapt to changing priorities.
  • Excellent communication and documentation skills.
  • Must be proficient using MS Windows and Microsoft Office applications.
  • Experience in Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
  • Excellent technical writing.