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.