Validation Engineer

LHH Recruitment Solutions has partnered with a growing organization, and they are seeking a motivated Validation Engineer to join their team in Lincolnshire, IL. You will play a crucial role in ensuring the safety, quality, and compliance of the company's products and processes. The ideal candidate will have a strong background in quality assurance and regulatory standards within the medical device or pharmaceutical industry. Competitive Salary and Benefits Package (PTO, Medical, Dental, Vision, Retirement, and Life Insurance) are offered.

Key Responsibilities:

Oversee, evaluate, and calibrate equipment, systems, and procedures used in product development and production.

Ensure compliance with ISO 13485, EU-MDR, ISO 14971, QSR 21CFR 820, QSR 21CFR 803, and cGMP 210 and 211 standards.

Support quality systems compliance through the maintenance of calibration systems and equipment databases.

Develop, execute, and maintain validation protocols and files to demonstrate regulatory compliance.

Consult with management and assess customer requirements to select validation objectives and standards.

Prepare protocols for validation or performance testing of new or modified manufacturing equipment, processes, or systems.

Analyze data from validation tests to determine if systems and processes meet required criteria and specifications.

Collaborate with various departments to schedule and implement validation testing.

Identify root causes of production problems and nonconformities, offering recommendations for resolving deviations.

Develop and maintain databases for tracking test results, validation activities, and validated systems.

Modify testing methods or revisit test objectives and standards to resolve testing problems.

Calibrate equipment to ensure accurate measurements.

Provide quality support for product development and change control.

Represent design quality functions for the review and approval of designated design outputs.

Qualifications and Skills:

Bachelor’s Degree in Engineering or a related field is required; a Master’s degree is preferred.

Minimum of 2+ years of experience in Quality Assurance or Quality Systems within an FDA-regulated industry (medical device or pharmaceutical).

Knowledge and application of QSR/GMP/GCP/ISO regulations related to medical device manufacturing.

Calibration experience.

Experience managing Quality Management System (QMS) software.

Prior experience in conducting process and test method validations.

Blow-Fill-Seal experience is a plus.

Proficiency in Minitab and Excel for data analysis and statistical calculations.

Strong analytical and technical writing skills.

Ability to communicate ideas and information clearly and effectively, both verbally and in writing.

Ability to prioritize tasks and manage multiple projects simultaneously.

Detail-oriented with excellent time management skills.

LHH is a leader in permanent recruitment—and in the placement of top talent. Our areas of specialty include office administration, customer service, human resources, engineering, and supply chain and logistics. Please feel to check us out and apply for other opportunities if this role isn’t a perfect match.

Equal Opportunity Employer/Veterans/Disabled

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