Validation Engineer

Cadence Inc • Sturgeon Bay, WI

7h • Onsite

About The Position

We are seeking a highly motivated Validation Engineer onsite at Cranberry Twp., Sturgeon Bay, WI, Suffield, CT or Cranston, RI sites, to lead and support validation activities across multiple projects at our facility. This role is critical in ensuring compliance with regulatory standards (FDA, ISO 13485, 21 CFR Part 820), working closely with engineering, QA, and manufacturing teams.

Requirements

• Bachelor’s in Engineering, Life Sciences, or related field.
• 3+ years' experience in validation or quality in a regulated industry.
• Knowledge of FDA, ISO 13485, 21 CFR Part 820 standards.
• Proficiency in Microsoft Suite; experience with validation software.
• Strong communication, documentation, and analytical skills.

Nice To Haves

• Lean/Six Sigma certification
• experience with LMS systems.

Responsibilities

• Develop and execute validation protocols. (IQ, OQ, PQ, TMV)
• Maintain detailed validation documentation. (VMPs, reports, SOPs)
• Conduct risk assessments and manage change controls.
• Ensure regulatory compliance. (GMP, GLP, CSV, data integrity)
• Collaborate cross-functionally to support validation strategy and training.
• Monitor system performance and lead requalification activities.
• Qualify suppliers and vendors.
• Contribute to process improvements and continuous improvement initiatives.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level