Validation Engineer - Contractor
raleigh, NC
Full Time
Mid Level
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 [email protected].
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:
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 [email protected].
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
- 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
- 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
- Competitive hourly rate based on experience
- Duration and hours vary by project
- Travel may be required depending on client site location
Apply for this position
Required*