Job Description Summary
The Quality Software Validation Engineer will develop and execute validations to ensure regulatory compliance to established internal and external standards related to released product or current production. The individual will support the writing of validation protocols and reports, along with the gathering and analysis of data.
Job Description
We are the makers of possible
BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities.
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We believe that the human element, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us.
Job Responsibilities:
- As a Quality Software Validations Engineer, you will play a critical role in ensuring the integrity of our equipment, processes, and quality systems
- Develop and execute validations to ensure regulatory compliance to established internal and external standards related to released product or current production
- The individual will support the writing of validation protocols and reports, along with the gathering and analysis of data
- This role requires collaboration across departments to support product implementation, troubleshoot issues, and maintain compliance with our quality management system
- Validate equipment, processes, and software to ensure they meet regulatory requirements
- Manage documentation systems, including equipment control and validation records
- Develop, review, and approve standard operating procedures (SOPs), risk assessments, and validation protocols
- Analyze quality metrics and identify trends to inform improvement initiatives
- Responsible for understanding, communicating, and following current Good Manufacturing Practices (cGMP's).
- Investigate quality issues and implement corrective actions
- Extract, clean, and analyze data to address product/process performance issues
- Lead or contribute to internal projects for new product introductions and process improvements .
Education and Experience:
- Educational Background: Bachelor's degree in an engineering discipline (biomedical, mechanical, industrial, etc.)
- A minimum of 6-10 years' software validation experience is required.
- Experience: Strong experience in medical device or FDA-regulated industries, quality systems/assurance, or quality control
Knowledge and Skills:
- Knowledge of FDA Quality System Regulations (QSR) and International Organization for Standardization (ISO) requirements and/or regulations
- Tech Skills: Proficient in technical writing and Microsoft Office applications
- Bonus Qualifications: Experience in computer programming, graphic design, or photo editing.
Physical Demands:
- Sitting and work on computer, moderate work on the production floor, moderate walking.
At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.
For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.
Why Join Us?
A career at BD means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a place where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day.
To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At BD, you'll discover a culture in which you can learn, grow, and thrive. And find satisfaction in doing your part to make the world a better place.
To learn more about BD visit https://bd.com/careers
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
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Primary Work Location
USA TX - El Paso - Northwestern Dr.
Additional Locations
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