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Serialization Engineer (PA)

Validation & Engineering Group Inc.
Allentown, PA Full Time
POSTED ON 2/22/2025
AVAILABLE BEFORE 5/18/2025

Validation & Engineering Group USA, Inc. (V&EG USA) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas : Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We partner with Contract Manufacturing Organizations (CMOs) to deliver top-tier services in packaging and serialization. We are currently seeking a highly skilled Serialization Engineer to join our team and support our client in delivering excellence in product traceability and data integrity.

Job Description :

We are looking for an experienced Serialization Engineer with a minimum of 5 years of experience in the pharmaceutical industry. The ideal candidate will have a deep understanding of serialization challenges and experience with Optel's Pharmaceutical Serialization Solution for fast compliance. The engineer will be responsible for ensuring accurate traceability of production and / or packaging data, maintaining compliance with regulations, and ensuring that all required information is accurately transferred as needed.

Key Responsibilities :

  • Develop, implement, and maintain 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 including IT, quality, production, and client representatives 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.
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