Engineer II, Validation

At Thermo Fisher Scientific, we are seeking a highly experienced and skilled Engineer II, Validation to join our team. As a leading global biotechnology company, we pride ourselves on our innovative solutions and cutting-edge technology. In this role, you will be responsible for providing technical expertise and leadership in the validation of our products and processes. The ideal candidate will have a strong background in engineering, with a passion for ensuring the quality and reliability of our products. If you are looking for a challenging and rewarding career in a dynamic and fast-paced environment, we encourage you to apply for this exciting opportunity.

1. Lead validation activities for product and process development, ensuring compliance with company and regulatory standards.
2. Develop and execute validation protocols, including IQ/OQ/PQ, to ensure the reliability and quality of our products.
3. Utilize statistical analysis and other validation tools to assess product and process performance.
4. Collaborate with cross-functional teams to identify and resolve any issues related to product quality and reliability.
5. Develop and maintain validation documentation, including reports and protocols.
6. Stay updated on industry trends and regulations related to validation and incorporate them into our processes.
7. Train and mentor junior engineers and technicians on validation procedures and best practices.
8. Conduct risk assessments and implement corrective and preventive actions to ensure compliance and continuous improvement.
9. Participate in product and process design reviews to ensure validation requirements are considered.
10. Communicate validation results and recommendations to management and other stakeholders.
11. Conduct validation studies at external contract manufacturing sites to ensure compliance with company standards.
12. Support regulatory inspections and audits related to validation activities.
13. Continuously monitor and improve the validation process to increase efficiency and effectiveness.
14. Collaborate with suppliers to ensure their components meet our validation requirements.
15. Act as a subject matter expert for validation-related topics and provide guidance to other departments as needed.

According to JobzMall, the average salary range for a Engineer II, Validation in Greenville, NC, USA is $74,000 - $88,000 per year. This range can vary depending on factors such as experience, education, and the specific company or industry the engineer is working in. Additionally, benefits and bonuses may also impact the overall salary for this position.

Thermo Fisher Scientific is a U.S.-based provisioner of scientific instrumentation, reagents and consumables, and software and services to healthcare, life science, and other laboratories in academia, government, and industry.