Validation Engineer - Manufacturing Engineering
Job Title: Validation Engineer - Manufacturing Engineering
Location: Easton, PA
Salary: $100,000 - $145,000 + 4%-8% bonus
Summary:
A reputable manufacturing company is seeking an experienced, hands-on Validation Engineer (Manufacturing Focused) for their Easton, PA facility.
Responsibilities:
The ideal Validation Engineer (Manufacturing Focused) will have the following responsibilities:
- Develop and maintain product requirements, Design Verification Plans & Reports (DVP&Rs), and validation standards to ensure clear traceability between product requirements and verification activities.
- Lead verification and validation efforts by defining stage-gate exit criteria, reviewing high-risk programs, and partnering with Product Design and Industrial Engineering teams throughout product development.
- Create, qualify, and continuously improve test methods, including test fixtures, instrumentation, environmental testing, data acquisition systems, and measurement standards to support product validation.
- Establish and govern manufacturing process and equipment validation standards, including IQ/OQ/PQ protocols, measurement systems analysis (MSA), process capability studies, sampling plans, and Design of Experiments (DOE) methodologies.
- Analyze warranty and field reliability data to identify failure trends, develop accelerated life testing strategies, support CAPA/8D investigations, drive product and process improvements, and mentor engineers on validation, reliability, and statistical best practices.
Qualifications:
The ideal Validation Engineer (Manufacturing-Focused) will have the following skill set:
- Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering
- Minimum of 10 years of progressive experience in product validation, verification, reliability, test, or quality engineering within a manufacturing and product development environment.
- Must have experience with Design Verification Plan and Reports (DVP&Rs)
- Must have experience with Installation Qualifications, Operational Qualifications, and Performance Qualifications (IQ/OQ/PQ)
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