The Validation Engineer is responsible for performing commissioning, qualification, validation (CQV) and engineering activities for solid dosage pharmaceutical manufacturing and packaging equipment, facilities and critical utility systems.
Responsibilities: Responsibilities include, but are not limited to:
• Prepare and execute commissioning (URS, FAT, SAT) and qualification/validation (IQ, OQ, PQ) protocols/documents per required quality standards.
• Read, understand, verify and develop P&ID, engineering layout, engineering drawings and engineering documents.
• Prepare and execute packaging engineering studies, develop line trials and assist in enhancing packaging process efficiencies.
• Prepare, review and record keeping of packaging set-up sheets containing critical machine specifications.
• Prepare and execute qualification and temperature mapping studies for warehouse storage area and special temperature and/or RH controlled areas.
• Maintain the annual calibration program for critical process instruments (temperature controllers, pressure gauges, data loggers, etc.) to ensure they are calibrated in timely manner.
• Maintain the annual program and record keeping of documentation for compressed air testing, clean room certifications, HEPA filter testing.
• Prepare clear SOPs and assist in providing personnel training for set-up, operation and maintenance of manufacturing and packaging equipment, utility systems and qualifications.
• Assist in assessment for gap analysis, carrying out investigations for process deviations and corrective actions as needed and change controls for modifications and process enhancements to improve efficiency and quality.
• Organize and maintain documents for equipment including manuals, drawings and calibrations.
• Coordinate with other departments, as needed for engineering and validation projects
• Other responsibilities as assigned by Senior Management.
Education and Experience:
• Bachelor’s degree in Engineering or other related field plus 2-3 years of Experience in Pharmaceutical, Biotech, Food or Cosmetic manufacturing industry required. OR
• Master’s degree in Engineering or other related field plus 0-1 years of Experience in Pharmaceutical, Biotech, Food or Cosmetic manufacturing industry required.
• Knowledge of FDA, cGMP/ 21 CFR guidelines for Part 210, 211 and Part 11.
• Experience with pharmaceutical manufacturing, packaging and utility equipment (HVAC, water systems, compressed air systems) preferred.
Skills and Abilities:
• Excellent oral and written communications skills and organizational skills.
• Technical writing skills preferred
• Ability to prioritize and multitask in a fast paced environment
• Ability to interact clearly and concise with all levels of personnel