Role: Process Validation Engineer

Location: Sturtevant, WI

We are seeking Process / Equipment Validation Engineers to support the installation, commissioning, qualification, and validation of 50+ silicone injection molding machines within a regulated manufacturing environment.

This is a hands-on, fast-paced role within a small organization where engineers are expected to take ownership of validation workstreams, proactively identify gaps, and drive execution with minimal oversight.

Key Responsibilities

• Support equipment installation, commissioning, and qualification (IQ/OQ/PQ) for silicone injection molding machinery
• Assist with new tooling installation and tooling replacement/changeovers
• Author, execute, and review validation documentation, including:
• URS
• Risk Assessments (FMEA or equivalent)
• IQ / OQ / PQ protocols and reports
• Traceability matrices
• Lead hands-on protocol execution, testing, and data analysis
• Support process validation activities following equipment qualification
• Collaborate with Engineering, Manufacturing, Quality, and external vendors
• Ensure compliance with GMP, ISO 13485, and internal quality system requirements
• Maintain inspection-ready documentation and support audit readiness

Required Qualifications

• 5+ years of experience as a Process or Equipment Validation Engineer
• Hands-on experience executing IQ/OQ/PQ for manufacturing equipment
• Strong understanding of equipment qualification and validation lifecycle
• Experience working in ISO 13485 and/or GMP-regulated environments
• Proven ability to independently manage validation activities in a fast-paced setting

Preferred Qualifications

• Experience with injection molding equipment (silicone injection molding strongly preferred)
• Experience supporting tooling installation or tooling changeovers
• PPAP (Production Part Approval Process) experience
• Background in medical device or pharmaceutical manufacturing
• Experience working in a small or mid-sized manufacturing organization