Principal Engineer, Validation
Welcome to Baxter International, a global leader in innovative healthcare solutions. We are seeking a highly skilled and motivated Principal Engineer, Validation to join our dynamic team. As a Principal Engineer, you will play a critical role in ensuring the safety and efficacy of our products through validation processes. This is a unique opportunity for a talented individual to make a meaningful impact on the lives of patients worldwide. The ideal candidate will possess a strong background in engineering, exceptional problem-solving skills, and a passion for driving continuous improvement. If you are seeking a challenging and rewarding career in the healthcare industry, we invite you to apply for this role today.
- Develop and implement validation protocols for all new and existing products to ensure compliance with regulatory standards and guidelines.
- Lead and manage validation projects, including developing timelines, allocating resources, and coordinating with cross-functional teams.
- Conduct risk assessments and identify potential areas of improvement in current validation processes.
- Analyze and interpret validation data to identify trends and make recommendations for process improvements.
- Collaborate with R&D, Quality, and Manufacturing teams to ensure that all validation activities are completed in a timely and effective manner.
- Stay up-to-date with industry standards and regulatory requirements related to validation and ensure that all processes are in compliance.
- Develop and maintain validation documentation, including protocols, reports, and standard operating procedures.
- Train and mentor junior engineers on validation processes and best practices.
- Participate in continuous improvement initiatives to enhance the efficiency and effectiveness of validation processes.
- Act as a subject matter expert on validation during audits and inspections, providing necessary documentation and responding to any inquiries.
- Communicate validation results and recommendations to stakeholders, including senior management, in a clear and concise manner.
- Act as a liaison between Baxter and external partners, such as contract manufacturers, to ensure their validation processes meet our standards.
- Drive a culture of compliance and quality by promoting the importance of validation and its impact on patient safety.
- Lead investigations and corrective actions related to validation deviations and non-conformances.
- Contribute to the development and implementation of new validation strategies and technologies to improve overall product quality.
Extensive Experience In Medical Device Validation: The Ideal Candidate For A Principal Engineer, Validation Role At Baxter International Should Have A Strong Background In Validating Medical Devices. This Includes Experience In Developing Validation Protocols, Executing Tests, And Writing Validation Reports.
Knowledge Of Industry Regulations: As A Principal Engineer, Validation, It Is Important To Have A Deep Understanding Of Industry Regulations And Standards Such As Fda, Iso, And Cgmp. This Will Ensure That All Validation Activities Are In Compliance With These Requirements.
Strong Project Management Skills: A Principal Engineer, Validation Is Responsible For Leading And Managing Validation Projects. Therefore, The Candidate Should Possess Excellent Project Management Skills, Including The Ability To Prioritize Tasks, Manage Timelines, And Communicate Effectively With Cross-Functional Teams.
Technical Expertise: The Ideal Candidate Should Have A Strong Technical Background In The Medical Device Industry. This Includes Knowledge Of Product Design, Manufacturing Processes, And Quality Control. This Will Enable The Principal Engineer To Identify Potential Risks And Develop Effective Validation Strategies.
Leadership And Team Management Skills: As A Leader In The Validation Team, The Principal Engineer Should Possess Strong Leadership And Team Management Skills. This Includes The Ability To Motivate And Mentor Team Members, Provide Constructive Feedback, And Foster A Collaborative Work Environment.
Quality Assurance
Process Improvement
Project Management
Data Analysis
Technical Writing
Root Cause Analysis
Validation protocols
Team Leadership
Risk assessment
GMP compliance
Validation Strategies
Communication
Conflict Resolution
Leadership
Time management
creativity
Organization
Teamwork
Adaptability
Problem-Solving
Empathy
According to JobzMall, the average salary range for a Principal Engineer, Validation in Cleveland, MS 38732, USA is $116,000 - $158,000 per year. However, this can vary depending on factors such as experience, education, and the specific company or industry.
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Baxter International Inc. is a Fortune 500 American health care company with headquarters in Deerfield, Illinois. The company primarily focuses on products to treat hemophilia, kidney disease, immune disorders and other chronic and acute medical conditions.
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