Process Validation Engineer

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 + Bacheloru2019s 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: u2022 Medical, dental & vision u2022 Critical Illness, Accident, and Hospital u2022 401(k) Retirement Plan u2013 Pre-tax and Roth post-tax contributions available u2022 Life Insurance (Voluntary Life & AD&D for the employee and dependents) u2022 Short and long-term disability u2022 Health Spending Account (HSA) u2022 Transportation benefits u2022 Employee Assistance Program u2022 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 ( ) for other accommodation options.

Created: 2025-10-20