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Validation Engineer Biomedical Jobs in Raleigh, NC

Kymanox

Associate Project Manager

Morrisville, NC · On-site

Bachelor of Science Degree in Chemical, Biomedical, or Mechanical Engineering, or related technical ... Validation (Equipment, Facility, Utility, Process, Cleaning, Method, Computer) * Quality ...

Numotion

Rehab Technology Supplier

Apex, NC

... or biomedical engineering will be considered. * Minimum two (2) years' experience in Assistive Technology direct customer-related services or related field may be considered. * Must have valid ...

Numotion

Rehab Technology Supplier

Apex, NC · On-site

... or biomedical engineering will be considered. * Minimum two (2) years' experience in Assistive Technology direct customer-related services or related field may be considered. * Must have valid ...

Numotion

Rehab Technology Supplier

Apex, NC · On-site

... or biomedical engineering will be considered. * Minimum two (2) years' experience in Assistive Technology direct customer-related services or related field may be considered. * Must have valid ...

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All JobsValidation Engineer Biomedical JobsValidation Engineer Biomedical Jobs in Raleigh, NC

Validation Engineer Biomedical information

See Raleigh, NC salary details

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$50

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How much do validation engineer biomedical jobs pay per hour?

As of Jun 9, 2026, the average hourly pay for validation engineer biomedical in Raleigh, NC is $50.54, according to ZipRecruiter salary data. Most workers in this role earn between $38.32 and $61.44 per hour, depending on experience, location, and employer.

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.
What are popular job titles related to Validation Engineer Biomedical jobs in Raleigh, NC? For Validation Engineer Biomedical jobs in Raleigh, NC, the most frequently searched job titles are:
What job categories do people searching Validation Engineer Biomedical jobs in Raleigh, NC look for? The top searched job categories for Validation Engineer Biomedical jobs in Raleigh, NC are:
What cities near Raleigh, NC are hiring for Validation Engineer Biomedical jobs? Cities near Raleigh, NC with the most Validation Engineer Biomedical job openings:
Validation Engineer Biomedical jobs near you
Life Sciences - Account/Project Manager

Life Sciences - Account/Project Manager

Kymanox

Morrisville, NC

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 29 days ago

Job description

Is Kymanox the right fit for you?
You want to make a difference and have an impact...
You enjoy having an influence in your day-to-day work...
You are motivated by working alongside a team filled with
subject matter experts who will help you learn and grow...
You wake up every day and do what you do
... because patients deserve better.
If this sounds like you, you've come to the right place.
The Account/Project Managerbridges the gap between Account Management and Technical Operations, requiring you to navigate both client strategy and project execution.
Responsibilities:
Strategic Account Management & Sales Acumen
  • Relationship Building: Act as the primary point of contact for assigned Life Science accounts, building trusted, strategic relationships with key decision-makers.
  • Revenue Growth: Identify partnership and contract growth opportunities, follow up on warm leads, and help secure renewals to achieve revenue goals.
  • Solution Design: Write technical proposals and develop action plans for project opportunities, ensuring they align with client needs and Kymanox capabilities.
  • Reporting: Deliver quarterly business reviews and maintain accurate forecasting within the CRM.
Technical Project Leadership
  • Project Oversight: Provide technical project management support, including scheduling, budget oversight, risk management, and resource allocation.
  • Technical Excellence: Lead cross-functional teams of engineers and SMEs, ensuring deliverables comply with relevant standards and regulations (cGMP, FDA, etc.).
  • Project Lifecycle: Manage a portfolio of projects covering focus areas such as combination product commercialization, process validation, and technology transfer.
  • Methodology: Utilize the Kymanox PM Toolkit and PMI best practices to drive project success. Projects may include any of the following focus areas:
    1. Combination Product Commercialization (e.g., Biologic-Device, Drug-Device)
    2. Process and Product Development
    3. Process Validation and Validation Planning
    4. Process Improvement and Troubleshooting
    5. Technical Report Authorship, Review, and Formatting
    6. Manufacturing Investigations and CAPA/Deviation Closure
    7. Biologic Manufacturing Scale-Up and Technology Transfer
    8. FDA 483 and Warning Letter Remediation
    9. Process and Facility Design to Support Next Gen Drug Manufacturing
    10. Quality Management System Support
    11. Perform additional responsibilities as requested or assigned.
  • Perform additional responsibilities as requested or assigned.
Education:
Bachelor of Science Degree in Chemical, Biomedical, or Mechanical Engineering, or related technical discipline from an accredited institution. Advanced degree or industry certificates in project management (e.g., PMP, CAPM), six-sigma, engineering, quality, or regulatory affairs preferred but not required.
Experience:
  • 5+ years of experience in Account Management or Business Development, combined with at least 2+ years of direct Project/Program Management. Knowledgein two or more of the following practice areas:
    1. CGMP Manufacturing (Pharma, Biotech, Device)
    2. Validation (Equipment, Facility, Utility, Process, Cleaning, Method, Computer)
    3. Quality Engineering
    4. Process Engineering, Technical Services, Manufacturing Sciences
    5. Quality Control or Analytical Science
    6. Quality Assurance
    7. Regulatory Affairs
    8. Technology Transfer
    9. Clinical or Medical Services
    10. Late Stage Process or Product Development (Pharma, Biotech, Device)
Desired Aptitude and Skill Set:
  • Project Management in accordance with PMI.org and Kymanox best practices
  • Experienced in use of Project Management tools, such as Smartsheet, Microsoft Project, and Office Timeline
  • Works cooperatively in a matrixed team environment
  • Seasoned soft skills with the ability to motivate teams and navigate client conflicts with diplomacy.
  • Strong professional presence with excellent verbal, written, and presentation skills.
  • Self-starter who balances "doing things right" (managerial) with "doing the right thing" (leadership).
  • Ability to thrive in a fast-paced, growing, and dynamic work environment.
  • Able to lead high-profile projects with minimal supervision
  • Extremely detail-orientated and highly organized
  • Fast learner with initial confidence tackling new material
  • Tackle problems proactively, not waiting for problems to grow unnecessarily
  • Thrive in a fast-paced, growing, and dynamic work environment
  • Value and understand quality
  • Uncompromised honesty and integrity
Travel:
Local travel within the assigned region and surrounding areas is required. Up to 30% domestic and international travel may be required from time to time.
Career Development:
The position will evolve over time and more responsibilities may be added. Since Kymanox is a growing company, there are opportunities for advancement both within the currently defined role and in other functions within the organization.
Compensation:
Base salary is commensurate with experience, qualifications, and other intangibles evident during the interview process - as well as market conditions. Eligible for incentive program after 6 months of outstanding work.
Benefits:
Medical healthcare including dental and vision, short- and long-term disability, life insurance, matching 401(k) retirement plan, continuing education assistance, and other benefits.

About Kymanox:
Join Kymanox - a life sciences professional services company dedicated to life sciences who has successfully delivered over 4000 projects across 20+ countries. Become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today's biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates, and young professionals, to work on a variety of projects to gain increased learnings in Kymanox's service offerings and the life science industry as a whole.
Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC.
To learn more about our company, please visit our website:Life Science Solutions | Kymanox
Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.
Employment Type: Full-Time

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