Validation Engineer - Kenosha, WI

[Adarsh mallik]

Job Description – Validation Engineer

Job Title: Validation Engineer
Location: Kenosha, WI
Duration: Contract
Positions: 5

Job Summary

We are seeking an experienced Validation Engineer to support a pharmaceutical manufacturing project in Kenosha, WI. The ideal candidate will have strong experience in validation activities for aseptic liquid fill manufacturing equipment, with a focus on Autoclaves and Parts Washers. This role requires hands-on expertise in equipment qualification, cycle development, and validation execution within a GMP-regulated environment.

Key Responsibilities

• Execute and support equipment validation activities including IQ, OQ, PQ, and PV.
• Perform Cycle Development and validation studies for Autoclaves and Parts Washers.
• Develop, review, and execute validation protocols and reports.
• Ensure compliance with GMP, FDA, and industry regulatory requirements.
• Analyze validation data and prepare technical documentation.
• Collaborate with Manufacturing, Engineering, Quality Assurance, and Project teams.
• Support commissioning and qualification activities for aseptic manufacturing equipment.
• Identify and resolve validation-related issues while ensuring project milestones are achieved.

Required Qualifications

• Validation Engineer: Minimum 3+ years of validation experience.
• Senior Validation Engineer: Minimum 5+ years of validation experience.
• Strong experience validating Aseptic Liquid Fill Manufacturing Equipment.
• Hands-on expertise with Autoclaves and Parts Washers.
• Experience performing Cycle Development, IQ, OQ, PQ, and PV.
• Knowledge of GMP, FDA regulations, and validation lifecycle documentation.
• Strong technical writing and documentation skills.

Preferred Qualifications

• Pharmaceutical or biotechnology manufacturing experience.
• Experience supporting large-scale validation and commissioning projects.
• Familiarity with aseptic processing environments.