Validation Engineer

Job Title: Validation EngineerJob Description

This position offers an opportunity to provide validation and technical support for all facilities supporting Manufacturing and Distribution. The role involves coordinating and executing product and process validations in alignment with the Quality Department. Responsibilities include evaluating the operations of Manufacturing and Quality activities to ensure compliance with Quality Standards and Regulations, and recommending necessary corrections or improvements. The position also involves providing direct support to Quality Management and personnel regarding departmental operations and the Quality System.

Responsibilities

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  Oversee the operation of the Quality System process related to product, process, and test method Validation and Re-Validation.

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  Manage Installation, Operational, and Performance Qualification activities for equipment, products, or systems, including those requiring computerized operation/interfacing.

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  Coordinate the installation and proper configuration of new equipment.

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  Assist Manufacturers and R&D departments in the development and validation of new products and Manufacturing/Quality Control processes.

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  Review and approve internal operating procedures and specifications.

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  Capture and analyze data related to product deviations, non-conformances, CAPAs, scrap, and rework for Quality Improvement and reporting.

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  Provide leadership and direction to promote Quality Improvement Processes.

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  Support quality engineering for supplier changes and resolve issues with suppliers.

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  Identify new quality improvement initiatives/projects to enhance compliance, quality levels, and operational efficiencies.

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  Support training programs by delivering assigned tasks.

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  Assist with federal, state, and local regulatory inspections.

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  Support internal and vendor quality system audits.

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Essential Skills

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  2+ years in Medical Device or Pharmaceutical Industry.

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  2+ years in a Quality Role.

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  2+ years in a Validation Engineering Role.

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  Bachelor's Degree in Physical Science or Engineering, or equivalent experience.

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  Experience in quality engineering, quality assurance, and root cause analysis.

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Additional Skills & Qualifications

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  Preferred 2 years of experience with electromechanical devices.

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  Knowledge of quality requirements for medical device/pharmaceutical organizations.

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  Strong technical writing and problem-solving skills.

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  Experience with NCR/CAPA processes.

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  Proficiency in Microsoft Word, Excel, PowerPoint, Visio; Adobe; and Quality System Management Software.

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  Experience with Statistical Analysis of Data and statistical sampling requirements for Process Validation.

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  Familiarity with ISO Quality System Standards, FDA Quality System Regulations, GMPs, and/or other international medical device regulations.

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  Highly effective communication skills.

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  Ability to manage multiple priorities and work with interruptions.

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  Capacity to work with minimal supervision and make effective decisions for diverse and complex issues.

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Work Environment

The role involves working in both an office environment and on the manufacturing floor to review and observe product processes. The work setting requires interaction with various company staff and effective communication throughout the organization.

Job Type & Location

This is a Contract position based out of Franksville, Wisconsin.

Pay and Benefits

The pay range for this position is $45.00 - $52.00/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 Franksville,WI.

Application Deadline

This position is anticipated to close on Oct 10, 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.