FAQs
What are the main responsibilities of a Principal Engineer, Process/Equipment Validation?
The main responsibilities of a Principal Engineer, Process/Equipment Validation include setting the strategic direction for validation programs, managing project plans and timelines, leading validation activities such as Commissioning and Qualification, Performance Qualification, Cleaning Validation, Process Validation, and Revalidation, overseeing equipment and process qualification lifecycle, managing the introduction of new equipment and products, leading investigations and root cause analysis, preparing validation documentation, and ensuring compliance with regulations and standards.
What qualifications and requirements are necessary for a Principal Engineer, Process/Equipment Validation?
To qualify for a Principal Engineer, Process/Equipment Validation role, candidates should have a BS/MS in chemical, biochemical engineering or related field, with at least 12 years of experience in drug product Process Research & Development, Engineering, Manufacturing, or Technical Services in the pharma/biotech industry. They should have hands-on experience in aseptic processing, knowledge of cGMPs, expertise in equipment qualification, project management skills, and excellent written and oral communication skills.
Is remote work possible for a Principal Engineer, Process/Equipment Validation?
This position is not eligible for full-time remote work arrangements.