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Haumiller Engineering
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 EngineerPosition OverviewWe 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
Key ResponsibilitiesDevelop 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.
QualificationsBachelors 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 executing
Demonstrated experience planning and conducting FAT and SAT activities and working with external vendors.
Working knowledge of regulatory and industry standards such as
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.
BenefitsMedical insuranceDental insurance
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 ResponsibilitiesDevelop 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.
QualificationsBachelors 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 executing
DQ/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 as
GMP, 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.
BenefitsMedical insuranceDental insurance
- employer paidVision Insurance
- employer paidShort and Long-term disability
- employer paidBasic Life and AD&D
- employer paidVoluntary Life insurance401(k) with company contributionPension planEmployee Stock Ownership Program (ESOP)Paid time offWellness Reimbursement8 paid holidays