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Validation Engineer - Equipment & Validation (Medical Device)
Job Description
Our client, a Global Leader in the Medical Device Industry has an immediate opening for a Validation Engineer - Equipment & Automation for a 12-month + Contract. Our client offers results-driven people a place where they can make a difference - every day! You will also have the opportunity to work with other like-minded, self-directed, and detail-oriented Top Talents in an extremely collaborative and professional environment.
We are seeking a Validation Engineer to lead and support validation activities for manufacturing equipment and automation systems in a regulated medical device environment. This role is responsible for ensuring equipment and automated systems are installed, qualified, and maintained in compliance with FDA, ISO 13485, and other applicable regulations.
Responsibilities
- Develop and execute validation protocols (IQ/OQ/PQ) for new and modified equipment and automation systems.
- Author and review validation plans, summary reports, and risk assessments.
- Collaborate with engineering, quality, and manufacturing teams to define validation requirements and acceptance criteria.
- Ensure equipment meets URS (User Requirement Specifications) and is validated in accordance with cGMP and 21 CFR Part 11.
- Perform data analysis and troubleshooting during validation activities to ensure performance and reliability.
- Maintain validation documentation and ensure audit readiness.
- Support equipment lifecycle activities including change control, re-validation, and periodic reviews.
- Contribute to continuous improvement initiatives involving equipment performance, process optimization, and compliance.
Job Requirements
Requirements
- Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related discipline).
- 3+ years of validation experience in a medical device or pharmaceutical manufacturing environment.
- Strong knowledge of FDA QSR, ISO 13485, GAMP 5, and 21 CFR Part 11.
- Experience validating automated equipment, robotics, or vision inspection systems preferred.
- Excellent documentation and communication skills.
- Proficiency with Microsoft Office and validation management systems
Preferred Skills:
- Six Sigma or Lean Manufacturing certification.
- Familiarity with PLCs, SCADA systems, and cleanroom/GMP environments.
- Experience supporting FDA inspections or third-party audits.
