Job Information
Sartorius Sterilization validation engineer in United States
As a Sterility Validation Engineer, you will be responsible for ensuring the sterility of products by utilizing core skills and a strong technical knowledge of appropriate standards, procedures, methods, and techniques, as well as current good manufacturing practices and state-of-the-art practices. In this role, you will support the implementation, maintenance, and improvement of this process at overseas manufacturing sites.
As a Sterility Validation Engineer, you will be responsible for ensuring the sterility of products by utilizing core skills and a strong technical knowledge of appropriate standards, procedures, methods, and techniques, as well as current good manufacturing practices and state-of-the-art practices. In this role, you will support the implementation, maintenance, and improvement of this process at overseas manufacturing sites.
Grow with us - Your Responsibilities
Implement and optimize sterility validation according to the established validation plan and strategy.
Establish a plan and coordinate the project at the local site based on the global process.
Support the maintenance of validation as described in the validation plan and procedures.
Provide training at local manufacturing sites.
Draft and revise Standard Operating Procedures (SOPs).
Support customer audits and inspections.
Support continuous process improvement efforts.
Provide support for new internal and sponsored projects, including reviewing protocols and reports.
Provide support in managing Out of Specification (OOS) issues.
Collaborate with staff to address and resolve deviations and incidents.
Follow up on corrective and preventive actions resulting from deviations and audit observations.
Your Profile
Bachelor's degree in microbiology, biotechnological engineering, or a related field.
5 years of relevant professional experience, including more than 2 years in the pharmaceutical or medical device environment.
Knowledge of relevant industry standards and practices with a demonstrated ability to interpret these regulations to ensure proper implementation in quality systems.
Good knowledge/experience in the pharmaceutical/medical device industry/laboratory good practices.
Ability to quickly acquire organizational skills, including the ability to effectively manage multiple processes and priorities, assess the requirements of assigned tasks cross-functionally, identify potential challenges, and communicate effectively to expedite the successful execution of assigned work.
Be a proactive force in strategic approaches.
Project management experience with different cultures.
Full proficiency 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