Validation Engineer

Validation Engineer

About the Role

We are hiring experienced Validation Engineers for a schedule-driven project in Kenosha WI. This role will focus on validation activities for aseptic liquid fill manufacturing equipment with a strong emphasis on autoclaves parts washers cycle development and PQ/PV execution.

Responsibilities

• Perform validation activities for aseptic liquid fill manufacturing equipment.

• Execute cycle development for autoclaves and parts washers.

• Perform PQ/PV activities on assigned equipment.

• Support IQ OQ and PQ validation documentation and execution.

• Review and document validation results accurately.

• Identify issues during validation runs and support resolution.

• Work closely with project engineering quality and operations teams.

• Maintain compliance with validation protocols and project timelines.

• Support a highly schedule-driven project environment.

• Work overnight 12-hour shifts on a 2-2-3 schedule.

Requirements

• Minimum 3 years of Validation Engineer experience required.

• Minimum 5 years of experience preferred for Senior Validation Engineer level.

• Strong validation experience in aseptic liquid fill manufacturing required.

• Autoclave and parts washer validation experience strongly preferred.

• Experience with cycle development required.

• Experience performing PQ/PV on manufacturing equipment required.

• Heavy IQ OQ and PQ experience with autoclaves and parts washers accepted.

• Ability to work mostly overnight shifts required.

• Must be comfortable working 12-hour shifts on a 2-2-3 schedule.

• Strong documentation communication and compliance skills required.

Step into a critical validation project where your aseptic manufacturing and equipment qualification experience can make an immediate impact.