
Senior Validation Engineer
Are you a highly motivated and experienced engineer looking to take the next step in your career? Do you have a passion for ensuring the quality and reliability of cutting-edge technology? Thermo Fisher Scientific is seeking a Senior Validation Engineer to join our team and play a crucial role in the validation of our products. In this role, you will use your expertise to develop and implement validation strategies, ensuring compliance with industry regulations and standards. If you are adept at problem-solving, detail-oriented, and have excellent communication skills, we encourage you to apply for this exciting opportunity.
Responsibilities:
- Develop and implement validation strategies for new products, processes, and equipment in accordance with industry regulations and standards.
- Plan and execute validation activities, including designing experiments, performing testing and analysis, and documenting results.
- Collaborate with cross-functional teams to ensure the timely completion of validation activities and adherence to project timelines.
- Conduct risk assessments and identify critical process parameters to ensure the reliability and quality of products.
- Create and maintain validation protocols, reports, and other documentation to support regulatory submissions and audits.
- Review and analyze validation data to identify trends and potential issues, and make recommendations for corrective actions.
- Develop and maintain relationships with external vendors and suppliers to ensure compliance with validation requirements.
- Train and mentor junior validation engineers and other team members on validation best practices and procedures.
- Stay current with industry trends and updates in regulations and standards related to product validation, and make recommendations for process improvements.
- Communicate validation status and findings to project teams, management, and other stakeholders in a clear and concise manner.
- Participate in continuous improvement initiatives to enhance validation processes and systems.
- Ensure all validation activities are conducted in a safe, ethical, and compliant manner.
- Act as a subject matter expert on validation processes, procedures, and best practices within the organization.
Bachelor's Degree In Engineering Or A Related Field, With A Focus On Quality Assurance Or Validation.
Minimum Of 5 Years Experience In A Validation Or Quality Assurance Role, Preferably In The Pharmaceutical Or Biotechnology Industry.
In-Depth Knowledge Of Gmp Regulations And Industry Standards For Validation, Including Fda And Eu Guidelines.
Strong Analytical And Problem-Solving Skills, With The Ability To Design And Execute Complex Validation Protocols.
Excellent Communication And Project Management Skills, With The Ability To Lead Cross-Functional Teams And Effectively Communicate With Stakeholders At All Levels.
Quality Assurance
Project Management
Data Analysis
statistical analysis
Technical Writing
Validation protocols
Risk assessment
Regulatory compliance
Test method development
Equipment Qualification
Gmp/Gdp
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Validation Engineer in Allentown, PA, USA is between $93,000 and $137,000 per year. This can vary depending on the specific company, years of experience, and level of education of the individual.
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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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