Quality Validation Engineer

Job Description:

Education: Bachelors in engineering Primary focus areas: Materials, Mechanical, Industrial, Chemical Engineering or Equivalent
Years of Experience: Minimum 2-5 years of significant engineering and/or operational experience is required. Experience with successfully performing IQ/OQ/PQ Qualifications and Change Request Management highly preferred.

A successful candidate will be able to do the following:
• Perform a variety of engineering assignments utilizing a wide range of engineering principles in a manufacturing and office environment.
• Lead and support IQ/OQ/PQ validations, partnering cross-functionally to achieve desired results.
• Manage multiple projects across development stages with accurate planning, timely delivery, and clear reporting on deliverables.
• Coordinate cross-functional teams (engineering, planning, quality, and technicians) to complete validation activities.
• Lead internal customer activities from implementation through validation completion.
• Champion continuous improvement of technology and processes.
• Demonstrate leadership, accountability, and strong collaboration within the team.
• Demonstrate strong technical writing skills.

Main Duties and Responsibilities:
• The Validation Engineer will lead and support cross-functional validation and implementation activities to qualify raw materials, processes, equipment, and systems, ensuring timely execution and compliant documentation.
• Plan and execute multiple validation and implementation projects across manufacturing platforms, from strategy through final report approval.
• Develop and qualify material, equipment, and process changes by authoring and executing protocols (IQ/OQ/PQ) and documenting results against acceptance criteria.
• Apply structured problem-solving (e.g., RCA/5-Why/FMEA) to investigate issues, define corrective actions, and prevent recurrence during validation and routine operations.
• Drive project management for qualification activities, including schedules, risk/issue tracking, stakeholder updates, and readiness for approval.
• Identify and implement improvements to manufacturing equipment, processes, and systems based on data analysis, investigations, and validation outcomes.
• Own validation documentation deliverables, including plans, protocols, executed test records, deviation investigations, final reports, and change control
submissions per the quality system.
• Troubleshoot unplanned downtime or excessive rejects during protocol execution by coordinating containment, documenting deviations, and defining re-test or recovery plans to complete validations.
• Prepare technical justifications for capital and expense requests, including scope, risk, benefits, and implementation/validation approach.

Required Experience:
• Hands-on experience supporting validation deliverables and technical documentation (DOE, IQ/OQ/PQ protocols and reports).
• Experience submitting test documentation and managing change requests/change control in a regulated quality system.
• Experience conducting nonconformance investigations, root-cause analysis, and CAPA support.
• Experience in a regulated industry (medical device preferred) with familiarity with FDA expectations.
• Working knowledge of statistics and Design of Experiments (DOE), including basic data analysis and interpretation.
• Six Sigma certification (Green Belt/Black Belt) is a plus.
• Strong analytical skills, including risk assessment and attention to detail in technical documentation.
• Ability to work independently, communicate effectively with stakeholders, and manage priorities; project management experience is preferred.
• Proven ability to work in a cross-functional matrix environment, build strong relationships, and serve as a subject matter expert when needed.
• Flexible and able to manage multiple priorities; willing to adjust schedule as required by business needs.
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