Software Validation Engineer

Job Title:

Software Validation Engineer

We are searching for a self‑motivated Senior Validation Engineer to join our Quality team. The primary focus of this position will be to validate computer systems software and systems. The candidate must have experience in all phases and deliverables of validation including, but not limited to, the development of requirements including process maps, risk analyses, plans, test protocols, and test reports to develop a validation master file.

Extensive software validation experience is a must. The work will be performed on‑site in Morrisville, NC.

• Validate computer systems software and systems.
• Develop requirements, process maps, risk analyses, plans, test protocols, and test reports.
• Ensure the Quality Management System meets US FDA requirements for equipment and computer systems validation.
• Collaborate with teams on‑site to develop and document requirements.
• Prioritize and manage multiple projects in a fast‑paced environment with minimal supervision.
• Adapt to changing priorities and manage multiple tasks efficiently.

• Experience in software validation and software quality assurance.
• Experience in the medical device industry and within a Quality System compliant with 21 CFR 820.
• 5+ years of experience in Computer System Validation for the Medical Device industry.
• Strong written and verbal communication skills.
• Ability to work autonomously and as a team player.
• Strong problem‑solving and decision‑making skills.

• BSc, MSc, or PhD in an engineering or physical science field.
• Experience with measurement methods and measurement equipment.
• Detailed knowledge of Microsoft Project, Smartsheet, or other project management software.
• Strong interpersonal skills.
• Experience with risk analysis and CAPA.

This position is onsite in Morrisville, NC. The role involves working with teams in a dynamic and fast‑paced environment, requiring flexibility and adaptability to shifting priorities. The work setting supports autonomy and encourages a collaborative team atmosphere.

This is a Contract position based out of Raleigh, NC.

The pay range for this position is $40.00 - $60.00/hr eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre‑tax and Roth post‑tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long‑term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

This is a fully onsite position in Raleigh, NC.

This position is anticipated to close on Mar 5, 2026.

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccom