Validation Engineer

Overview

Lead IQ/OQ/PQ validation, ensure compliance, support quality and production in med device.

Key Responsibilities

• validation
• tooling
• data analysis
• iq/oq/pq
• troubleshooting
• process transfer

Tasks

-Ensure equipment and processes comply with EHS and GMP requirements. -Develop and implement validation plans that meet regulatory and internal quality standards. -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. -Participate in complaint investigations and continuous improvement initiatives. -Interface with engineering, quality, and operations teams to support new product introductions. -Lead and execute IQ/OQ/PQ protocols for equipment, processes, and systems. -Author and maintain technical documentation, including validation reports, risk assessments, and change controls. -Troubleshoot and resolve production issues, collaborating with cross-functional teams. -Support non-conformance investigations, root cause analysis, and corrective actions. -Facilitate smooth transitions from development to production, ensuring process robustness.

Requirements

• bachelor's
• 2+ years
• iq/oq/pq
• cleanroom
• documentation
• validation

What You Bring

-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.

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Benefits

-Life Insurance (Voluntary Life & AD&D for the employee and dependents) -Health Spending Account (HSA) -Transportation benefits -Critical Illness, Accident, and Hospital -Medical, dental & vision -Time Off/Leave (PTO, Vacation or Sick Leave) -Short and long-term disability -401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available -Employee Assistance Program

About Actalent

-Born in July 2021 by merging Aerotek’s engineering & sciences arm with EASi, Actalent emerged as a focused engineering-and-science partner. -Backed by Allegis Group, it drives scale and speed to market via contract, managed, and technical services. -Headquartered in Maryland with global reach, it deploys specialized teams across North America, Europe, and APAC on Fortune 500 projects. -Typical engagements span EV design, vaccine development, lab services, clinical research, and infrastructure systems. -Expertise covers a wide spectrum: aerospace, defense, healthcare, manufacturing, software systems, environmental and civil engineering.

Sector Specialisms