
Validation Engineer
Are you passionate about ensuring the safety and effectiveness of life-saving medical devices and pharmaceutical products? Do you have a keen eye for detail and a strong understanding of compliance regulations? Thermo Fisher Scientific is seeking a highly motivated Validation Engineer to join our team and contribute to the development and validation of cutting-edge technologies that improve global health. As a Validation Engineer, you will have the opportunity to work with a dynamic and collaborative team to ensure the quality and reliability of our products. We are looking for candidates with a Bachelor's degree in Engineering or a related field, as well as experience in validation processes and FDA regulations. If you are a driven and dedicated individual with a strong commitment to quality, we encourage you to apply for this exciting opportunity.
- Develop and execute validation protocols for medical devices and pharmaceutical products according to established procedures and regulations.
- Conduct risk assessments and identify potential hazards in products and processes.
- Perform testing and analysis of data to ensure product safety and effectiveness.
- Collaborate with cross-functional teams to ensure compliance with FDA regulations and international standards.
- Review and provide input on design documents, change control records, and other relevant documents.
- Keep up-to-date with industry trends and advancements in validation techniques.
- Troubleshoot and resolve any issues related to product validation.
- Provide technical support and guidance to other team members.
- Maintain accurate and organized documentation of all validation activities.
- Continuously improve and streamline validation processes to increase efficiency and effectiveness.
- Communicate validation results to stakeholders and provide recommendations for improvement or corrective action.
- Participate in internal and external audits to ensure compliance with regulatory requirements.
- Collaborate with suppliers and third-party vendors to ensure their processes and products meet validation requirements.
- Mentor and train junior validation engineers on validation processes and procedures.
- Adhere to company policies, procedures, and safety regulations at all times.
Bachelor's Or Master's Degree In Engineering Or A Related Field.
Minimum Of 3 Years Of Experience In Validation, Preferably In The Medical Device Or Pharmaceutical Industry.
Strong Knowledge Of Regulatory Requirements Such As Fda, Iso, And Cgmp.
Experience With Validation Protocols, Execution, And Documentation.
Excellent Problem-Solving And Analytical Skills, With Attention To Detail And Accuracy.
Documentation
Quality Assurance
Troubleshooting
Data Analysis
statistical analysis
Instrumentation
Process validation
Risk assessment
Regulatory compliance
equipment calibration
Protocol Development
Test Protocols
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
Critical thinking
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Validation Engineer in Cincinnati, OH, USA is between $70,000 and $90,000 per year. This may vary depending on factors such as level of experience, specific job duties, and the company's industry and size. Some senior-level Validation Engineers may earn upwards of $100,000 per year.
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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.

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