Fort Worth Metro Area, TX
Support assigned validation activities in a timely manner and in line with cGMP requirements.
Author validation protocols and technical reports (e.g., Pre Validation Studies, Performance Qualifications, Requalifications, Annual Monitoring Batches).
Perform process qualification for new equipment and new technologies.
Contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation.
Understanding of manufacturing processes and related process equipment.
Working knowledge of applied statistics, quality systems and regulatory requirements.
Experience in executing process validation
Writing and reviewing protocols and technical reports.
Fundamental understanding of standard pharmaceutical analytical testing.
BSc in Chemistry, Microbiology, Pharmacy, Chemical Engineering, or Pharmaceutical Technology, or equivalent scientific or engineering degree. Fluent in English and proficient in site local language.