Equipment Validation Engineer - Kenosha, WI

[Adarsh mallik]

Job Description – Equipment Validation Engineer

Title: Equipment Validation Engineer
Location: Kenosha, WI
Duration: Contract

Job Summary

We are seeking an experienced Equipment Validation Engineer to support validation activities within a pharmaceutical manufacturing environment. The ideal candidate will have strong expertise in equipment qualification and process validation for aseptic liquid fill operations, with a focus on autoclaves and parts washers. This role requires hands-on experience executing validation protocols, cycle development, and qualification activities in compliance with GMP and regulatory requirements.

Key Responsibilities

• Execute and support Equipment Qualification activities including IQ, OQ, and PQ for manufacturing equipment.
• Perform cycle development, performance qualification (PQ), and process validation (PV) activities for autoclaves and parts washers.
• Develop, review, and execute validation protocols and reports.
• Ensure validation activities comply with FDA, cGMP, and industry standards.
• Troubleshoot validation issues and recommend corrective actions.
• Collaborate with Engineering, Manufacturing, Quality Assurance, and Regulatory teams.
• Analyze validation data and prepare technical documentation.
• Support deviation investigations, change controls, and CAPA activities related to validation.
• Maintain validation lifecycle documentation and ensure audit readiness.
• Participate in commissioning and qualification activities for new or modified equipment.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, or a related field.
• Minimum 3+ years of Validation Engineering experience in pharmaceutical or biopharmaceutical manufacturing.
• Strong experience with aseptic liquid fill manufacturing equipment validation.
• Hands-on experience with autoclave cycle development and qualification.
• Experience qualifying parts washers and cleaning equipment.
• Expertise in IQ, OQ, PQ, and Process Validation methodologies.
• Strong knowledge of FDA regulations, cGMP, and validation documentation practices.
• Excellent technical writing and communication skills.

Preferred Qualifications

• Experience in sterile manufacturing environments.
• Knowledge of risk assessments, change controls, deviations, and CAPA processes.
• Experience supporting regulatory inspections and audits

[Adarsh mallik]

• Experience supporting regulatory inspections and audits.