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Validation Engineer Biomedical Jobs in Texas (NOW HIRING)

Execute on the design, development, verification, and validation of new products, ensuring ... S. degree in Mechanical Engineering, Biomedical Engineering, or related field. * Minimum 5 years of ...

Execute on the design, development, verification, and validation of new products, ensuring ... S. degree in Mechanical Engineering, Biomedical Engineering, or related field. * Minimum 5 years of ...

Execute on the design, development, verification, and validation of new products, ensuring ... S. degree in Mechanical Engineering, Biomedical Engineering, or related field. * Minimum 5 years of ...

Showing results 21-40

Validation Engineer Biomedical information

What is the difference between Validation Engineer Biomedical vs Quality Assurance Engineer Biomedical?

AspectValidation Engineer BiomedicalQuality Assurance Engineer Biomedical
CertificationsGMP, ISO, FDA validation certificationsGMP, ISO, audit and compliance certifications
Work EnvironmentDesign, develop, and execute validation protocols for medical devicesDevelop and maintain quality systems, audits, and process improvements
Industry UsagePrimarily in medical device manufacturing and regulatory validationAcross medical device, pharmaceutical, and biotech industries

Validation Engineer Biomedical focuses on ensuring medical devices meet regulatory validation requirements through testing and protocols. Quality Assurance Engineer Biomedical emphasizes maintaining quality systems, compliance, and process improvements. Both roles are essential in the biomedical industry but serve different functions related to validation versus quality assurance.

What are some typical challenges faced by validation engineers in the biomedical industry and how can they be addressed?

Validation Engineers in the biomedical field often face challenges such as keeping up with evolving regulatory requirements, managing complex documentation, and ensuring equipment or processes meet stringent quality standards. Navigating audits and working cross-functionally with R&D, manufacturing, and quality assurance teams can also be demanding. To address these challenges, staying current with industry regulations, developing strong organizational and communication skills, and maintaining meticulous records are essential for success and career growth in this role.

What are the key skills and qualifications needed to thrive as a validation engineer in biomedical?

To thrive as a Validation Engineer in Biomedical, you need a solid background in engineering or life sciences, knowledge of regulatory standards (such as FDA or ISO 13485), and experience with validation protocols. Familiarity with technical tools like statistical analysis software, calibration equipment, and documentation systems is essential, and certifications such as Six Sigma or CQE can be advantageous. Strong problem-solving, attention to detail, and effective communication skills help you excel in cross-functional teams and ensure compliance. These skills are crucial for maintaining product quality, meeting regulatory requirements, and ensuring patient safety in biomedical environments.

What does a validation engineer do in biomedical?

A Validation Engineer in the biomedical industry ensures that equipment, processes, and systems used in the production of medical devices or pharmaceuticals meet regulatory standards and function as intended. Their work involves planning and executing validation protocols, documenting results, and troubleshooting any deviations. This role is crucial for maintaining product quality, patient safety, and compliance with regulatory agencies such as the FDA. Validation Engineers often collaborate with quality assurance, manufacturing, and research teams to establish and maintain validated systems throughout a product's lifecycle.
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Full-time

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Job description

We are the people who give possibilities purpose
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.
Job Description
Job Responsibilities:
Responsibilities include but are not limited to:
Process Optimization & Manufacturing Support
  • Provide day-to-day engineering support to pharmaceutical manufacturing operations.
  • Analyze manufacturing processes to identify opportunities for improving efficiency, quality, yield, and cost.
  • Troubleshoot process issues and implement corrective and preventive actions (CAPAs).
  • Monitor process performance through data analysis and key performance indicators (KPIs).
  • Lead root cause investigations related to process deviations, nonconformances, and customer complaints.

Validation & Compliance
  • Support process validation, equipment qualification, and revalidation activities.
  • Develop and execute validation protocols, reports, and technical documentation.
  • Ensure compliance with FDA regulations, cGMP requirements, BD policies, and applicable quality standards.
  • Support internal and external audits, inspections, and regulatory commitments.
  • Maintain manufacturing documentation, standard operating procedures (SOPs), and work instructions.

Continuous Improvement
  • Lead Lean Manufacturing and Continuous Improvement projects.
  • Utilize Six Sigma, DMAIC, and problem-solving methodologies to eliminate waste and improve process capability.
  • Identify and implement productivity, quality, and cost-reduction initiatives.
  • Participate in site transformation and operational excellence programs.

Project Management
  • Support new product introductions, technology transfers, and process changes.
  • Coordinate engineering projects from conception through implementation.
  • Manage timelines, risk assessments, resource requirements, and project documentation.
  • Collaborate with Maintenance, Quality, Operations, Validation, Regulatory Affairs, and Supply Chain teams.

Safety & Quality
  • Promote a strong culture of safety, compliance, and quality.
  • Support risk assessments, process hazard evaluations, and quality improvement initiatives.
  • Ensure all engineering activities are performed following EHS and Quality Management System requirements.

Education and Experience:
  • Bachelor's degree in Chemical Engineering, Industrial Engineering, Mechanical Engineering, Biomedical
  • 3+ years of experience of engineering experience within a pharmaceutical, medical device, biotechnology, or highly regulated manufacturing environment
  • Experience working in FDA-regulated, cGMP, validation, and quality systems.
  • Experience in pharmaceutical manufacturing and aseptic or sterilization processes preferred.
  • Knowledge of process validation, equipment qualification (IQ/OQ/PQ), and risk management methodologies, preferred.
  • Lean Six Sigma Green Belt or Black Belt certification preferred.
  • Experience with SAP, TrackWise, MES, or other manufacturing systems preferred.
  • Knowledge of statistical tools and process capability analysis.
  • Bilingual (English/Spanish) preferred.

Knowledge and Skills:
Technical Skills
  • Strong analytical and problem-solving skills.
  • Experience conducting root cause investigations and implementing CAPAs.
  • Proficiency in Microsoft Office applications and data analysis tools.

Key Competencies
  • Strong problem-solving and analytical skills
  • Detail-oriented with data-driven decision making
  • Ability to manage problem solving and critical thinking
  • Effective communication and collaboration across all levels

Physical Demands:
  • Manufacturing environment with exposure to production areas.

Work Environment:
  • Manufacturing

Why Join Us?
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 healthcare. At BD, you'll discover a culture in which you can learn, grow and thrive.
We believe that when people connect in person, we learn faster, collaborate more deeply, and build a stronger culture. Join us and enjoy a culture where face-to-face collaboration supports your learning, your progress, and your success.
To learn more about BD visit https://bd.com/careers.
Becton, Dickinson, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to 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, and other legally protected characteristics.
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Primary Work Location
USA TX - El Paso - Northwestern Dr.
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About BD

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BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.

Industry

Medical equipment and supplies manufacturing and manufacturing

Company size

10,000+ Employees

Headquarters location

Franklin Lakes, NJ, US

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