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
- 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
- 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
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