STAFF VALIDATION ENGINEER in Marburg (m/w/d)-BEC015644
Beckman Coulter develops, manufactures and markets products that simplify, automate and innovate complex biomedical testing. Our diagnostic systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use our life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs. More than 275,000 Beckman Coulter systems operate in both diagnostics and life sciences laboratories on all seven continents. For 80 years, our products have been making a difference in peoples’ lives by improving the productivity of medical professionals and scientists, supplying critical information for improving patient health and reducing the cost of care.
Beckman Coulter offers a broad array of comprehensive, competitive benefit programs that add value to associates' and their families' lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits. We think you'll like what you see.
If you believe your education and experience are in line with the position description and qualifications referred to above, and are motivated, energetic, and looking for a new and exciting opportunity, please submit your resume online at the URL below or at www.beckmancoulter.com
Beckman Coulter is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.
The Staff Verification & Validation Engineer will be a member of a team responsible for equipment validation, process validation and Excel spread sheet validations. The individual will be responsible for identifying requirements, and perform planning and development of validation strategies, characterization studies and test protocols/reports in a self-dependent manner. The Staff Validation Engineer ensures that the validated process and equipment meet specifications and fulfill the intended purpose. The engineer collaborates with other functional groups, including Product Development, Quality Assurance, Manufacturing, and Manufacturing Engineering. The engineer ensures that company, industry, and regulatory standards met.
Planning and monitoring of validation projects and qualification projects and their implementation.
Creating validation strategies, validation protocols and validation reports to perform IOPQ for equipment and process.
Business leadership in validation projects; support other functional groups in assisting in the processes validation and software applications
Responsibility for the development and maintenance of the documents for validation according to the requirements of international standards and regulations such as ISO 13485:2016, ISO 14791-2007 and 21 CFR 820.
Create policies and instructions and ensuring GMP-compliant documentation;
Creating and training of quality-related procedures and processes
Bachelor’s degree in Chemical, Mechanical or Biomedical Engineering or other similar baccalaureate degree, master degree is an advantage
5 or more years of relevant experience in process validation within a regulated industry
Good understanding of validation methodologies with ability to evaluate system specifications and requirements for completeness and testability
Able to generate test protocols and procedures from specifications and to execute test procedures manually, with minimal guidance
Analysis of measurement data; creating failure statistics; Experience in Statistics / Engineering Analysis.
Experience with FDA or other Regulated Process and ISO standard such as 13485:2016 and 21 CFR 820 is highly desirable
Knowledge of GMP and GDP is required
Must have good written and oral communication skills in English and German
Danaher Corporation Overview
Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.
Organization: Beckman Coulter - Diagnostics
Job Function: Quality and Regulatory Affairs
Primary Location: EMEA-Western Europe-Germany-Hessen-Marburg