Validation Engineer

Job Title:

Validation Engineer

Job Description

As a Validation Engineer, you will perform validations for current projects, including thermal mapping projects, shipping validations, QC Lab data, and more. You will support the establishment and achievement of performance metrics and objectives that represent leading industry Validation Programs. You'll ensure assigned projects are completed within approved timelines and budgets, maintaining consistent communication with internal customers and stakeholders regarding changes in priority, status, and timeline.

Collaborate with co-workers and management across departments to implement validation strategies, plans, and protocols for assigned projects in accordance with written procedures and industry best practices. You will also write documents and process them through company systems while staying up-to-date with current industry trends, and ensuring compliance with Quality Systems, ISO
13485, cGMP, and other relevant regulatory protocols. Additionally, you will provide support for internal and external audits and Quality System investigations.

Responsibilities

+ Perform validations for thermal mapping projects, shipping validations, and QC Lab data.

+ Support the establishment and achievement of performance metrics and objectives for Validation Programs.

+ Complete assigned projects within approved timelines and budgets.

+ Maintain consistent communication with internal customers and stakeholders regarding project changes.

+ Collaborate with co-workers and management across departments.

+ Implement validation strategies, plans, and protocols according to written procedures and industry best practices.

+ Write and process documents through company systems.

+ Stay updated with industry trends and ensure compliance with regulatory protocols.

+ Provide support for internal and external audits and Quality System investigations.

Essential Skills

+ Experience in process validation and temperature controls.

+ Ability to perform shipping validations, including temperature validation of products during transit.

+ Proficiency in risk assessments, PFMEA, statistical analysis, and statistical process control.

+

Experience with validation protocols, medical device validation, and batch record review.

Additional

Skills & Qualifications

+ Experience in stability testing and stability validations.

+

Experience with QC Lab Testing.

+ Familiarity with manufacturing process validation, thermal profiles, and validations for refrigerated/frozen chain shipments.

Work Environment

This position requires working on-site every day, Monday through Friday, from 8 am to 5 pm. The role involves working across various areas including manufacturing, shipping, analytical lab, and production lab areas. There is potential to work from home one day per week, depending on business needs and workload, usually on Fridays pending manager approval.

Job Type & Location

This is a Contract position based out of Waukesha, WI.

Pay and Benefits

The pay range for this position is $35.00 - $45.00/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 Waukesha,WI.

Final date to receive applications

This position is anticipated to close on Feb 28, 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 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 actalentaccom (%20actalentaccom)  for other accommodation options.