Sterilization Validation Engineer

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.