Project Qualification Engineer

Work with operations personnel on quality and safety issues

Strategic planning for qualification aiming to complete as per customer promised timelines.

Lead and assist with Factory and Site acceptance (FAT/SAT) testing and IQ/OQ/PQ including documentation review and reporting.

Perform detailed Root cause analysis for customer complaints pertaining to Qualification.

Participate in development of Qualification team, GEMBA meetings, sprints, and log progress through completion

Ability to take-around a BIO Process equipment with customers during Factory Acceptance test

Oversee the perfection of Qualification protocols.

Profile require travel 60-70% both Domestic and globally

The Customer Quality Professional will be responsible for interpreting, building upon, and complying with company service standards. The holder of this position will carefully maintain complaint and nonconformance processing through records and tracking systems, including root cause and corrective actions.

Main Responsibilities & Tasks

• Inspect or verify services are compliant with applicable requirements
• Plan, organize and conduct audits/assessments of supplier's systems, processes and products
• Work with services to close out any audit findings
• Document and report audit/assessment results
• Facilitate quality issues in conjunction with key stakeholders, resolving day to day problems
• Perform effective containment and problem resolution for all non-conformances
• Report and assess status of service performance
• Provide education and coaching on quality systems, regulatory compliance issues and company initiatives
• Provide support for product development
  
  

Qualification & Skills

• Bachelor degree in a relevant science, engineering or related subject
• Minimum 5 years' experience in a quality and assurance development ideally within the biomedical or pharmaceutical industry
• Professional Certification — In depth knowledge of Quality auditing, and regulatory standards
• Good Technical Engineering knowledge, including ability to understand engineering drawing and standards
• Ability to develop realistic work plans, set personal goals that align with company goals
• Well-organized and methodical, with a superb attention to detail
• Ability to prioritize and manage daily assignments
• Excellent written and verbal communications skills to represent the company professionally
• Establish and maintain positive working relationships with all inand external interfaces
• Fluent in English
  
  

About Sartorius

Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.

We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.

Join our global team and become part of the solution. We are looking forward to receiving your application.

www.sartorius.com/careers