Pharmaceutical engineer vs validation engineer

Differences between pharmaceutical engineer and validation engineer duties and responsibilities

Pharmaceutical engineer example responsibilities.

• Manage overall validation programs for the GMP products at the manufacturing facility and the contract manufacturing company.
• Participate in regulatory agency inspections (FDA, EU) as a subject matter expert and minimize findings.
• Develop skills in process change control, aseptic technique and gowning, validation, FDA audits and writing manufacturing tickets.
• Prepare installation qualification, operational qualification, and performance qualification (IQ/OQ/PQ) protocols and reports.
• Expedite and simplify the quotation process for solar water heating systems by accurately representing solar water heating system performance through MATLAB models
• Provide plant technical input for all modifications affecting EQ equipment.
Show more

Validation engineer example responsibilities.

• Manage the DFMEA and risk assessment/mitigation as development are on-going.
• Manage a team of 15 technicians testing Intel's wireless products across all Microsoft's OS offerigns.
• Coordinate a division of labor and manage next steps to validate SVM on Broadwell (BDW) client CPU.
• Manage CSV quality compliance by meeting factory, corporate, federal and foreign inspections demonstrating regulatory control with no major findings.
• Work with end users from different departments, possess strong analytical and risk assessment skills and managing multiple GLP system projects.
• Coordinate and manage daily CIP validation testing activities.
Show more