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E
Everforth
Validation Engineer
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Based on Illinois data
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What they do
A Validation Engineer evaluates and maintains machinery and equipment used in manufacturing, and supervises workers that use and repair the machines.
$91,886 / year median in Illinois
-2% projected decline
Job Description
Validation Engineer Validation Engineer Position Overview We are seeking a Validation Engineer to plan, execute and document facility, equipment and system validations to ensure they meet design and regulatory requirements. The role focuses on developing and executing
DQ/IQ/OQ/PQ
protocols, performing FAT and SAT activities, and partnering with engineering, quality and operations to maintain compliant, reliable manufacturing systems and continuous improvement initiatives using Lean Manufacturing principles. Key Responsibilities Develop and review validation strategies, protocols and reports for equipment, processes and computerized systems (DQ/IQ/OQ/PQ). Plan, lead and execute Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT); coordinate third-party vendors as required. Perform execution of installation and operational checks, collect and analyze test data, and prepare final validation summaries and deviation reports. Collaborate with cross-functional teams (Engineering, Quality, Manufacturing, IT) to ensure validation requirements are understood and implemented. Maintain validation documentation in accordance with company procedures and regulatory requirements (GMP, FDA, ISO). Support change control, CAPA and qualification activities; evaluate impact of changes and lead re-validation when necessary. Conduct risk assessments, define acceptance criteria, and ensure traceability of requirements through testing. Drive continuous improvement by applying Lean Manufacturing tools to reduce waste and optimize validation and commissioning workflows. Support supplier qualification and FAT oversight for new equipment purchases; review vendor documentation and test protocols. Qualifications Bachelors degree in Engineering (Mechanical, Electrical, Chemical, Biomedical, or related field) or equivalent experience. 3+ years of hands-on experience in equipment and process validation within regulated industries (pharmaceutical, biotech, medical device, or similar). Proven experience writing and executingDQ/IQ/OQ/PQ
protocols and summary reports. Demonstrated experience planning and conducting FAT and SAT activities and working with external vendors. Working knowledge of regulatory and industry standards such asGMP, GAMP5, 21 CFR
Part 820/11 and ISO standards relevant to manufacturing/quality. Familiarity with Lean Manufacturing principles and experience applying continuous improvement tools in validation or production environments. Strong technical skills with industrial control systems (PLCs, HMIs, SCADA) and computerized system validation (CSV) preferred. Excellent documentation, communication and problem-solving skills, with attention to detail and ability to manage multiple projects and stakeholders. Willingness to travel to supplier sites and manufacturing locations for FAT/SAT as required. Benefits Medical insurance Dental insurance- employer paid Vision Insurance
- employer paid Short and Long-term disability
- employer paid Basic Life and AD&D
- employer paid Voluntary Life insurance 401(k) with company contribution Pension plan Employee Stock Ownership Program (ESOP) Paid time off Wellness Reimbursement 8 paid holidays For this position, you must be currently authorized to work in the United States without the need for sponsorship for a non-immigrant visa.