Validation Engineer - Contractor

MEDVACON TALENT ACQUISITION, LLC; Raleigh (NC); On-site; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a skilled Validation Engineer to join their consulting team. This role involves ensuring compliance with regulatory standards for medical devices, focusing on validation lifecycle activities. You will lead projects, develop protocols, and collaborate with various teams to enhance quality systems. If you have a strong background in validation engineering and a passion for quality assurance, this is an excellent opportunity to make a significant impact in a dynamic environment. Join a forward-thinking company where your expertise will be valued and your contributions will drive success.

Qualifications

• 5+ years of experience in validation engineering in the medical device industry.
• Strong knowledge of FDA regulations and ISO 13485 standards.

Responsibilities

• Lead validation projects including Installation Qualification (IQ) and Performance Qualification (PQ).
• Collaborate with teams to ensure validation documentation is accurate.

Skills

Validation Engineering

FDA Regulations

ISO 13485

GxP Principles

Technical Documentation

Problem-Solving

Communication Skills

Education

Bachelor’s degree in Engineering

Bachelor’s degree in Life Sciences

Tools

Statistical Tools

Risk Management Tools (FMEA, HACCP)

Job description

2 days ago Be among the first 25 applicants

Get AI-powered advice on this job and more exclusive features.

Important Notice: Protecting Your Information

Medvacon Talent Acquisition only conducts initial video interviews via Microsoft Teams or Zoom. All communication will come from an email address ending in @medvacon.com. If you receive a message that seems suspicious or is not from our official domain, please report it immediately to [e-mail].

This is a temporary 6-month contracted 1099 position.

Position Overview:

We are seeking an experienced Validation Engineer to join our consulting team to support medical device clients in ensuring compliance with regulatory standards and internal quality systems. This role requires hands-on experience with validation lifecycle activities in a regulated environment, including equipment qualification, process validation, and cleaning validation. The consultant will work collaboratively with client teams to design, execute, and document validation protocols that meet FDA and international regulatory requirements.

Key Responsibilities:

• Lead and execute validation projects including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)
• Develop and write validation protocols, risk assessments, and final reports
• Ensure validation activities comply with FDA 21 CFR Part 820, ISO 13485, and relevant GAMP guidance
• Support equipment and process validation efforts related to manufacturing, packaging, and cleaning
• Collaborate with Quality Assurance, Engineering, and Production teams to ensure validation documentation is accurate and complete
• Participate in deviation investigations and support implementation of corrective and preventive actions (CAPA)
• Provide technical guidance and validation expertise to clients during audits and inspections
• Assist in developing or improving validation strategies and procedures for client systems
  
  

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or related technical field
• Minimum of 5 years of experience in validation engineering within the medical device industry
• Strong knowledge of FDA regulations, ISO 13485, and GxP principles
• Experience with validation of manufacturing equipment, automated systems, and cleanroom environments
• Proficient in writing and reviewing technical documentation
• Strong problem-solving and communication skills
• Ability to work independently or as part of a team in a client-facing role
• Prior consulting experience a plus
  
  

Preferred Skills:

• Experience with computer system validation (CSV)
• Familiarity with statistical tools and data analysis techniques
• Knowledge of risk management tools such as FMEA and HACCP
• Experience in both startup and mature manufacturing environments
  
  

Contract Details:

• Competitive hourly rate based on experience
• Duration and hours vary by project
• Travel may be required depending on client site location
  
  

Powered by JazzHR

aDxCkZJM4d

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Internet Publishing

Referrals increase your chances of interviewing at MEDVACON TALENT ACQUISITION, LLC by 2x

Get notified about new Validation Engineer jobs in Raleigh, NC.

Senior Validation & Quality Systems Engineer

Raleigh-Durham-Chapel Hill Area 2 weeks ago

Durham, NC $70,000.00-$95,000.00 2 weeks ago

Quality Engineer, DSM Operations (Nights)

Triangle, NC $60,000.00-$70,000.00 6 months ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.