Validation Engineer

LHH Recruitment Solutions has partnered with a growing organization, and they are seeking a motivated Validation Engineer -- Medical Device / Pharmaceutical Manufacturing to join their team. This is a high-impact role supporting critical manufacturing and quality systems, with direct visibility to leadership and the opportunity to influence compliance strategy, process validation, and product quality across the organization. This position is ideal for someone who thrives in a regulated environment and enjoys working cross-functionally to ensure products are manufactured safely, effectively, and in full compliance with FDA and ISO 13485 standards.

• Lead validation efforts for manufacturing equipment, processes, and systems, ensuring compliance with regulatory and internal quality standards.
• Author, execute, and maintain validation protocols and reports (IQ, OQ, PQ) for new and existing processes.
• Support and maintain calibration programs and equipment tracking systems to ensure accuracy and audit readiness.
• Partner with Engineering, Manufacturing, and Quality teams to plan and implement validation activities across the product lifecycle.
• Analyze data from validation and testing activities to confirm system performance and compliance with specifications.
• Investigate nonconformances, identify root causes, and recommend corrective and preventive actions (CAPA).
• Develop and maintain validation documentation, including protocols, reports, and supporting quality records.
• Provide quality support for design control activities, including risk management, change control, and product development initiatives.
• Ensure alignment of validation and quality processes with QMS requirements and regulatory expectations.
• Act as a subject matter expert during audits and regulatory inspections.

• Bachelor’s Degree in Engineering or related technical discipline.
• 2+ years of experience in Quality Assurance, Validation, or Quality Systems within medical device or pharmaceutical manufacturing industry.
• Hands‑on experience developing and executing IQ/OQ/PQ validation protocols.
• Strong understanding of FDA and ISO regulatory frameworks, including: 21 CFR Part 820 and Part 803, ISO 13485 and familiarity with ISO 14971, cGMP requirements for manufacturing environments.
• Experience working within a Quality Management System (QMS) environment and utilizing QMS software platforms.
• Exposure to Device Master Records (DMR), design controls, and risk management principles.
• Working knowledge of calibration programs and equipment validation.

$80,000 - $100,000

2 weeks of vacation, paid sick leave where applicable by state law, Medical Insurance, Dental Insurance, Vision Insurance, 401K, and Life Insurance.

Equal Opportunity Employer / Veterans / Disabled