Ensuring compliance with global regulatory and industry standards for the storage, handling, and transportation of pharmaceutical products by maintaining validated systems and processes for distribution.
Requirements
- 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.
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.
- Provide technical expertise for change control, CAPA, and deviation management related to storage and distribution.
Other
- 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).
- Strong oral and written communication skills.
- Ability to document, plan, and execute programs.
- We will not sponsor individuals for employment visas, now or in the future, for this job opening.
- Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
