What are the responsibilities and job description for the Process Validation Engineer position at Actalent?
Process Validation Engineer - Medical Device Manufacturing
Overview
Seeking a Process Validation Engineer to lead equipment and process validation efforts, ensuring compliance with regulatory and company standards. This role supports product quality, process improvement, and production readiness.
Responsibilities
- Lead and execute IQ/OQ/PQ protocols for equipment, processes, and systems.
- Develop and implement validation plans that meet regulatory and internal quality standards.
- Author and maintain technical documentation, including validation reports, risk assessments, and change controls.
- Design and qualify tooling, fixtures, and test methods to support manufacturing and R&D.
- Conduct process characterization and data analysis for work-in-progress components.
- Troubleshoot and resolve production issues, collaborating with cross-functional teams.
- Support non-conformance investigations, root cause analysis, and corrective actions.
- Ensure equipment and processes comply with EHS and GMP requirements.
- Facilitate smooth transitions from development to production, ensuring process robustness.
- Participate in complaint investigations and continuous improvement initiatives.
- Interface with engineering, quality, and operations teams to support new product introductions.
Qualifications
- Bachelor’s in Engineering (Mechanical, Biomedical, or related discipline).
- 2 year experience in validation, quality, or manufacturing.
- Familiarity with IQ/OQ/PQ, cleanroom practices, and documentation control.
Pay and Benefits
The pay range for this position is $35.00 - $41.34/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 Lakes,FL.
Application Deadline
This position is anticipated to close on Oct 30, 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.
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 actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $35 - $41