Validation Engineer

Validation Engineer

The Validation Engineer leads process validation for automation and equipment capital projects, drives validation for new equipment installations and process improvements, and ensures seamless transfer of validated processes into production in a regulated medical device environment.

Responsibilities

• Prepare, author, and execute validation documentation to ensure all automated systems and process improvements are fully validated (IQ/OQ/PQ) and compliant with 21 CFR Part 820 and other applicable standards prior to release to production.
• Evaluate and define validation strategies that enable quick, robust, and compliant transfer of processes and equipment into production.
• Maintain Agile-controlled process and equipment documentation, including standard operating procedures (SOPs), process flow charts, electrical drawings, 2D/3D equipment drawings, equipment parameter lists (CP), and equipment logic programs (LCP).
• Ensure strict compliance with FDA Quality System Regulations (QSR) and relevant product-specific regulations and standards (such as IEC and ISO requirements).
• Drive operational and regulatory excellence across validation activities and related quality processes.
• Lead validation activities for any process changes, including creating, approving, and executing validation protocols from scratch.
• Support the implementation of new equipment and new or upgraded processes, working closely with R&D and Quality teams in a highly integrated environment.
• Ensure that all process and equipment changes meet medical device validation and quality standards.
• Maintain strong, open communication with cross-functional teams to ensure alignment, timely issue resolution, and clear documentation of decisions.
• Plan and execute the full validation lifecycle, including URS (User Requirement Specifications), FAT (Factory Acceptance Testing), SAT (Site Acceptance Testing), IQ/OQ/PQ (Installation, Operational, and Performance Qualifications), validation protocols and execution, and associated instructional and operating documents as well as quality handbooks.
• Assist with automation and equipment capital projects from concept through installation and full validation, ensuring readiness for production use.
• Work in a hands-on manner with processes and equipment on the factory floor when needed to understand, test, and validate systems.
• Champion Lean, Six Sigma, and Design for Manufacturability/Design for Assembly (DFM/DFA) principles across internal operations and outsourced manufacturing partners.
• Apply Scrum methodology to project work by breaking large projects into milestones and 1–2 week sprints, conducting sprint planning to define short-term deliverables, and participating in regular stand-ups to track progress and remove obstacles.
• Perform heavy documentation tasks using Word and Excel, including reviewing quality handbooks and requirements, and completing and signing validation documentation.
• Contribute to a collaborative, growth-oriented environment focused on innovative, life-saving medical devices with global impact on patient care.

Essential Skills

• 3+ years of experience in medical device validation, with a strong focus on process validation and regulatory compliance.
• Bachelor's degree in a related field and 3–5 years of relevant work experience.
• Approximately five years of experience working in the medical device field.
• Proven experience with IQ/OQ/PQ and end-to-end process validation in a regulated environment.
• Strong experience in medical device quality engineering and familiarity with FDA QSR, 21 CFR Part 820, and applicable IEC and ISO standards.
• Ability to prepare, complete, and interpret complex validation reports and technical documentation.
• Good computer skills, including strong proficiency with Microsoft Excel and other Office tools used for documentation and data analysis.
• Experience creating, approving, and executing validation protocols from scratch for new and modified processes and equipment.
• Hands-on experience working with manufacturing equipment and automated systems in a production or factory setting.
• Ability to work within Agile documentation frameworks and maintain accurate, up-to-date process and equipment records.
• Experience applying Scrum methodology to validation and engineering projects, including sprint planning and participation in regular stand-ups.
• Strong communication skills to maintain open, effective collaboration with R&D, Quality, and other cross-functional teams.
• Ability to review and apply requirements from quality handbooks and regulatory documents.

Additional Skills & Qualifications

• Experience with Lean and Six Sigma methodologies and a demonstrated ability to drive continuous improvement in validation and manufacturing processes.
• Knowledge of Design for Manufacturability (DFM) and Design for Assembly (DFA) principles and their application to equipment and process design.
• Experience with Agile documentation tools and workflows for managing SOPs, drawings, and validation records.
• Familiarity with URS, FAT, SAT, and the full equipment qualification lifecycle in a medical device context.
• Ability to work effectively in a Scrum-based environment, including breaking down large projects into milestones and short sprints.
• Comfort working in a highly integrated environment with R&D and Quality teams, as well as outsourced manufacturing partners.
• Capability to complete reports and documentation in multiple languages, including Spanish, is beneficial.
• Strong attention to detail, organization, and documentation discipline in a highly regulated environment.
• Motivation to contribute to innovative, life-saving medical devices and to work in a growth-oriented, globally impactful setting.

Work Environment

This role is primarily office-based, with approximately 80–90% of time spent in the office focused on documentation, analysis, and collaboration, and the remaining time spent on the factory floor in a hands-on capacity with equipment and processes. The core validation team consists of about four validation professionals who work closely with an additional group of around six R&D colleagues in a highly integrated environment. The position follows a first-shift schedule with flexible hours, and there is flexibility to work from home for appointments on an as-needed basis. The environment emphasizes collaboration, Agile practices, and continuous improvement, using tools such as Word and Excel for heavy documentation and quality handbooks for guidance. The setting supports innovative, life-saving medical device development and offers a professional atmosphere focused on quality, regulatory compliance, and global impact on patient care.

Job Type & Location

This is a Contract position based out of Noblesville, IN.

Pay and Benefits

The pay range for this position is $48.08 - $55.29/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 Noblesville, IN.

Application Deadline

This position is anticipated to close on Jul 16, 2026.

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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