ATL01-091924 Serialization Engineer (PA)

Validation & Engineering Group • Allentown, PA

44d

About The Position

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 Optels 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.

Requirements

• Bachelors 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 Optels 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Personal and Laundry Services
• Number of Employees: 101-250 employees