Job Title: Validation Engineer

Location: Mundelein, IL

Salary: $78,000-$92,000

LHH Recruitment Solutions is currently seeking a Validation Engineer to join our client's organization in the Mundelein, IL area.

Key Responsibilities

• Validation and Calibration: Oversee, evaluate, and calibrate equipment, systems, and procedures used in the development and production of products to ensure safety, quality, and compliance
• Protocol Preparation: Prepare protocols for validation or performance testing of new or modified manufacturing equipment, processes, or systems
• Data Analysis: Analyze data from validation tests to determine whether systems and processes meet required criteria and specifications
• Collaboration: Collaborate with various departments and staff regarding the scheduling or implementation of validation testing
• Problem Identification: Identify root causes of production problems and nonconformities of product or process standards, offering recommendations for resolving deviations
• Documentation: Develop, maintain, and review validation and compliance documentation, including schematics, protocols, and engineering change notices
• Equipment Calibration: Calibrate equipment to ensure accurate measurements and maintain the calibration system and equipment database
• Quality Support: Provide quality support for product development, change control, and ensure compliance with regulatory requirements and quality standards
• Training and Guidance: Train others and provide guidance on compliance with quality management systems and regulatory standards

Qualifications

• Education: Bachelor’s degree required, MS preferred
• Experience: 5+ years of experience in Quality Assurance or Quality Systems in a regulated industry (e.g., medical device, pharmaceutical)
• Regulatory Knowledge: Knowledge and application of QSR/GMP/GCP/ISO regulations related to manufacturing
• Technical Skills: Experience with QMS software, process and test method validations, and calibration
• Analytical Skills: Strong analytical and technical writing skills, with the ability to communicate ideas and information clearly and effectively
• Project Management: Ability to prioritize tasks, manage multiple projects, and work independently or as part of a team
• Detail-Oriented: Must be extremely detail-oriented with excellent time management skills
• Physical Requirements: Ability to sit, stand, reach, and walk for prolonged periods of time

Benefits:

• Competitive salary
• Health, dental, and vision insurance
• 401(k) with company match
• Paid time off and holidays
• Professional development opportunities
• Employee assistance program

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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