Process Validation Engineer

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