Validation Engineer

Job Description

The Validation Engineer is responsible for ensuring the accuracy, reliability, and compliance of inspection methods used in the manufacturing of medical devices. This role focuses on validating automated inspection programs in accordance with FDA, ISO, and ICH guidelines. The ideal candidate will have experience with automated optical inspection systems, including those integrated into Coordinate Measuring Machines (CMMs) and vision measuring systems. Strong technical writing skills are essential for developing validation protocols, test scripts, and reports.

Responsibilities

• Develop and execute validation protocols (IQ, OQ, PQ) for inspection methods, ensuring compliance with FDA, ISO, and ICH guidelines.
• Validate inspection programs for automated optical inspection systems, including CMMs and vision measuring systems.
• Conduct risk assessments and define validation acceptance criteria based on statistical analysis and industry best practices.
• Collaborate with Quality, Engineering, and Manufacturing teams to ensure inspection methods meet product and regulatory requirements.
• Analyze and document validation results, authoring comprehensive reports and justifications for validation conclusions.
• Maintain validation documentation to support audits and regulatory submissions.
• Investigate validation-related nonconformances and recommend corrective actions as needed.
• Stay up to date with industry regulations and best practices for validation of automated inspection systems.

Essential Skills

• Engineering Degree
• 3 Years Validation Experience
• IQ/OQ/PQ
• Test Method Validation
• Technical Writing

Additional Skills & Qualifications

• Experience with FDA, ISO, and ICH guidelines
• Proficiency in Minitab
• Strong Quality Inspection skills

Work Environment

This is an onsite position. Growing medical device company in Miami, FL.

Pay and Benefits

The pay range for this position is $43.27 - $52.88/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)

Workplace Type

This is a fully onsite position in Miami,FL.

Application Deadline

This position is anticipated to close on Mar 31, 2025.

About Actalent

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.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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 process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $43 - $53