Process Validation Engineer

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 #J-18808-Ljbffr