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Validation Engineer Biomedical Jobs in Washington

Axle

Data Engineer

Rockville, MD · On-site

$116K - $140K/yr

... validation, and delivery of complex biomedical datasets. You will collaborate closely with scientists, researchers, data scientists, bioinformaticians, application developers, and technical ...

Axle

Data Engineer

Rockville, MD

$116K - $140K/yr

... validation, and delivery of complex biomedical datasets. You will collaborate closely with scientists, researchers, data scientists, bioinformaticians, application developers, and technical ...

Axle

Data Engineer

Rockville, MD · On-site

$116K - $140K/yr

... validation, and delivery of complex biomedical datasets. You will collaborate closely with scientists, researchers, data scientists, bioinformaticians, application developers, and technical ...

Axle

Data Engineer

Rockville, MD · On-site

$116K - $140K/yr

They are seeking a Data Engineer to support biomedical science, clinical research data integration ... Implement data validation checks, reconciliation routines, testing practices, and monitoring ...

IT EXCEL LLC

Jr QA Tester

Mount Rainier, MD · On-site

$55K - $58K/yr

... IN RESTON, VA Title: Jr. Validation Engineer/QA Analyst/ Jr. QA Tester/Business Analyst/BA ... Qualifications Qualifications : BS in Biomedical Engineering/ BS in Chemical Engineering/ Computer ...

IT EXCEL LLC

Jr QA Tester

Mount Rainier, MD · On-site

$55K - $58K/yr

... IN RESTON, VA Title: Jr. Validation Engineer/QA Analyst/ Jr. QA Tester/Business Analyst/BA ... Qualifications Qualifications : BS in Biomedical Engineering/ BS in Chemical Engineering/ Computer ...

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All JobsValidation Engineer Biomedical JobsValidation Engineer Biomedical Jobs in Washington

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, and why are they important?

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 the biomedical field?

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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What job categories do people searching Validation Engineer Biomedical jobs in Washington look for? The top searched job categories for Validation Engineer Biomedical jobs in Washington are:
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Validation Engineer Biomedical jobs near you

Validation Engineering Roles

Barry Wehmiller Group

Columbia, MD

Full-time

Posted 25 days ago

Job description

About Us:

BW Design Group is a fully integrated architecture, engineering, construction, system integration, and consulting firm committed to helping our clients realize their most critical goals from Strategy to Commercialization. As the only firm born from a manufacturing technology company to become an independent and fully integrated firm, we combine deep domain expertise in the manufacturing environment with an approach that is built to serve the dynamic needs of our clients. Rooted in our distinct culture of Truly Human Leadership, we cultivate the leaders who will define tomorrow and partner with our clients in the food & beverage, life sciences, industrial, and advanced technology industries to build the future of manufacturing and technology.


 

Barry-Wehmiller is a diversified global supplier of engineering consulting and manufacturing technology for the packaging, corrugating, sheeting and paper-converting industries. By blending people-centric leadership with disciplined operational strategies and purpose-driven growth, Barry-Wehmiller has become a $3 billion organization with nearly 12,000 team members united by a common belief: to use the power of business to build a better world.


 

Job Description:

Who You'll Work With

Join one of our 45 offices in the US as part of a committed team of over 1500 professionals, working directly with clients on projects that shape the world around us. As a contract professional with BW Design Group,you'llbe welcomed into a rapidly growing business and empowered to make an immediate impact.You'llwork alongside seasoned leaders, technical specialists, and subject matter experts within our Regulatory Compliance Practice to deliver the highest quality solutions with consistency and accuracy.

What You'll Do

You'llsupportbothcapital projectCQV delivery and individual technical contributionsolutions for our clientswithinthe Life Sciencesindustry.You'llhelp clientsimplementcritical changes to improve their performance and realize their most important goals through:

Validation & ComplianceActivities:EstablishUser Requirement Specifications for critical equipment and systems.Assess risk across various aspects ofsystems' functionsandfocus efforts on critical quality aspects.Develop and execute validation and FDA compliance related documents/protocols for pharmaceutical equipment and processes- employing industry's most progressive Digital Validation Tools Prepare, execute, and manage commissioning and qualification documents for utility, facility, and process equipment Perform FAT, SAT, IQ, and OQ documentation development and execution on Automated Systems Conduct investigations and troubleshoot validation-related issues Prepare comprehensive written validation reports.

Project Management & Leadership: Lead all aspects of client relationship development and project execution Develop project plans, strategies, and manage project resources, budgets, and schedules Oversee complete project lifecycle from concept through design, implementation, installation, commissioning, and startup Manage multiple project responsibilities simultaneously with excellent organizational skills Focus on project success related to scope, schedule, budget, and client satisfaction

What You'll Bring

Experience Requirements(Based on Role Level):

Validation Engineer II:Minimum2-7yearsproject experience with validation of automation, packaging, utilities, and/or facilities in pharmaceutical or medical device environments

Sr. Validation Engineer:Minimum7+yearsdemonstratedexperience with pharmaceutical or medical device process and equipment validation

Sr. Project Manager:Minimum10+yearsproject engineering, design engineering, or project management experience with packaging, processing, automation, or Life Science applications.

Technical Skills & Qualifications: Bachelor's degree in Engineering (Bioengineering, Biomedical, Chemical, Electrical, Mechanical, or equivalent technical degree) Validation experience in automation, packaging, cleaning, computer systems, utilities, and/or facilities Strong technical writing and oral communication skills Proficiency with project documentation and computer skills (Microsoft Office, Microsoft Project, AutoCAD) Experience with entire project lifecycle from concept development through startup (preferred)

ProfessionalAttributes:Excellent leadership and organizational skills with ability to manage multiple responsibilities Outstanding communication and interpersonal skills to interact with all levels of management, clients, and vendors Flexibility with tasks and strong analytical capabilities Willing and able to travel as necessary for project requirements including installation, startup activities, client meetings, and industry events.

#LI-TH1

"Must be legally authorized to work in theUnited stateswithout sponsorship"


 

At Barry-Wehmiller we recognize that people come with a wealth of experience and talent beyond just the technical requirements of a job. If your experience is close to what you see listed here, please still consider applying. We know that our differences often can bring about innovation, excellence and meaningful work-therefore, people from all backgrounds are encouraged to apply to our positions. Please let us know if you require reasonable accommodations during the interview process.

Barry-Wehmiller is an equal opportunity employer. M/F/D/V This organization uses E-Verify.


 

Applicants may be subject to pre-employment screening which may include drug screening, reference checks, employment verifications, background screening and/or skills assessments.


Company:

Design Group

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