Validation Engineer

United Pharma; Wisconsin; On-site; USD 90,000 - 120,000; Full time

Job summary

A leading healthcare company is seeking a Senior Validation Engineer to provide onsite support for Commissioning, Qualification, and Validation (CQV) and Equipment Validation activities in Wisconsin. The ideal candidate will have 8-10 years of experience in Validation Engineering, with a strong background in medical device manufacturing. Responsibilities include leading CQV activities, performing IQ, OQ, and PQ processes, and developing validation documentation. This role presents an exciting opportunity to enhance quality processes in a dynamic environment.

Qualifications

• 8–10 years of experience in Validation Engineering.
• Strong hands-on experience with IQ/OQ/PQ validation.
• Proven ability to write and execute validation documentation.
• Experience with risk assessment methodologies and optimization activities.
• Background supporting CDMO and medical device manufacturing environments.

Responsibilities

• Lead and execute CQV and Equipment Validation activities.
• Perform IQ, OQ, and PQ for manufacturing equipment.
• Develop, execute, and author validation protocols, reports, and SOPs.
• Conduct risk assessments and support process optimization.
• Perform API functional testing as part of equipment and process validation.

Skills

Validation Engineering

Equipment Validation

Risk Assessment Methodologies

Process Optimization

Tools

Bio Fillers

Cappers

Stoppers

Job description

Overview

Our client is seeking a Senior Validation Engineer to provide onsite support for Commissioning, Qualification, and Validation (CQV) and Equipment Validation activities. This role is based in Wisconsin and requires hands-on experience within a CDMO medical device manufacturing environment.

The ideal candidate will have a strong background working in manufacturing and contract manufacturing settings, with the ability to independently execute validation activities for production equipment.

Key Responsibilities

• Lead and execute CQV and Equipment Validation activities
• Perform IQ, OQ, and PQ for manufacturing equipment
• Develop, execute, and author validation protocols, reports, and SOPs
• Conduct risk assessments, support process optimization, and continuous improvement initiatives
• Perform API functional testing as part of equipment and process validation
• Collaborate closely with manufacturing, quality, and engineering teams

Equipment Experience

• Bio Fillers
• Cappers
• Stoppers

Required Skills & Experience

• 8–10 years of experience in Validation Engineering
• Strong hands-on experience with equipment validation (IQ/OQ/PQ)
• Proven ability to write and execute validation documentation
• Experience with risk assessment methodologies and optimization activities
• Background supporting CDMO and medical device manufacturing environments