GE HealthCare Validation Engineer 

United States, Illinois 

537322987

Validation Engineer – This role will be responsible for ensuring compliance with global regulatory and industry standards for the storage, handling, and transportation of pharmaceutical products. This role focuses on maintaining validated systems and processes for distribution, including transportation studies, packaging qualifications, and controlled shipping procedures. The engineer will develop and maintain SOPs, execute risk assessments, and ensure adherence to Good Distribution Practices (GDP) to safeguard product quality throughout the supply chain.
Roles and Responsibilities

• Lead and maintain validation programs for product storage and transportation systems, including thermal mapping, lane qualification, and packaging validation.

• Develop, review, and update SOPs governing controlled shipping and storage practices.

• Ensure compliance with WHO TRS 961 Annex 9 , USP <1079> Good Storage and Distribution Practices , EU GDP Guidelines , and PDA Technical Report 64 .

• Conduct risk assessments (e.g., FMEA, HACCP) for transportation and storage processes to mitigate temperature excursion risks.

• Manage and maintain documentation for transportation studies, packaging qualifications, and deviation investigations related to shipping/storage.

• Collaborate with cross-functional teams including Quality Assurance, Logistics, and external suppliers to ensure robust distribution processes.

• Support audits and inspections by providing evidence of compliance for storage and distribution systems.

• Provide technical expertise for change control, CAPA, and deviation management related to storage and distribution.

Required Qualifications

• Bachelor's degree in Engineering from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in technical roles in the pharmaceutical industry).

Desired Characteristics

• Strong oral and written communication skills. Ability to document, plan, and execute programs.

• 1+ years of experience in validation, quality, or engineering roles within pharmaceutical or biotech industries.

• Knowledge of temperature-controlled packaging systems, data loggers, and thermal qualification software.

• Familiarity with global GDP requirements and transportation management.

• Experience with ISPE GPG Cold Chain Management, WHO Annex 9, USP <1079>, EU GDP, and PDA TR 64.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

We will not sponsor individuals for employment visas, now or in the future, for this job opening.