Validation Engineer (Based in Binh Duong)

• Participation in the projects partially which related to the installations/ modification of systems that require validation/qualification works.
• Co-ordinate with relevant functions to prepares protocols for validation/ qualification: URS, FAT, SAT, DQ, IQ, OQ, PQ or performance testing of new or modified manufacturing equipment, processes, or systems.
• Supervising the Validation master Plan and ensure the periodic validations are performed on time
• Resolves CAPA&039;s, non-conformances, protocol incidents, and change controls related to validation protocols.
• Provides validation schedule and prepare risk assessments for new systems and equipment introduced to the facility.
• Analyzes data from validation tests to determine whether systems and processes meet required criteria and specifications.
• Develop and write commissioning, qualification and validation documents following established standards and templates.
• Investigates and conducts troubleshooting/root cause analysis of deviations out of specification
• Generate and execute validation protocols (IQ, OQ and PQ) for pharmaceutical drug manufacturing.
• Supervising the current status of validation documentation in the scope of its activities
• Perform validation activities for the facilities, utilities, manufacturing and laboratory equipment in the pharmaceutical industry
• Responsible for temperature and humidity mapping and startup of new facility Controlled Temperature Units, Stability Chambers, Warehouse Space, storage room/area

MINIMUM BACKGROUND/ EXPERIENCE REQUIRED
Core Skill Requirement
• Good communication skills in English and Vietnamese
• Analytical thinking
• Flexibility and adaptability
• Computer skills
• Intermediate knowledge of utilities system (HVAC, purified water, compressed air, etc.) and manufacturing equipment of pharmaceutical industry, computerized system)
• Strong documentation and record-keeping skills
• Problem-solving skills
• Time management skills and the ability to work on your own initiative
Core Trait/Behavior Requirement:
• Teamwork and working independently
• Patience in the workplace
MINIMUM EDUCATION REQUIRED
• Major in Mechanical or Electrical Engineering
• Graduate or Undergraduate level

Cập nhật gần nhất lúc: 2022-05-29 08:12:04