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Validation Engineer

Location : Saddle Brook NJ US 07663
Job Type : Direct
Reference Code : 21155-BZ1
Compensation : 85000.00 - 95000.00 USD/YEAR
Start Date : 08/30/2022
Hours : Full Time
Required Years of Experience : 3
Required Education : BS Mechanical Engineering
Travel : No
Relocation : No
Job Industry : Medical Devices

Job Description :

  • Permanent position for a Mechanical Engineer to serve as the primary Validation Engineer with responsibility for ensuring all equipment and manufacturing processes are qualified and validated to internal, external and industry standards.

  • Establish all aspects of a validation project; including: authoring/reviewing/executing Validation Master Plan (VMP) and Procedure, Validation Plan (VP), User Requirements Specifications (URS), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols / report, risk assessments, and periodic validation / qualification reviews.

  • Develop the Company’s validation plan and strategy, execution and implementation.

  • Create and maintain a current validation schedule.

  • Submit reports regarding scope and status of validation activity.

  • Analyze information and draw conclusions based upon technical knowledge of the systems.

  • Work with different groups / departments to ensure correct interpretation and execution of information and protocols.

  • Coordinate validation activities between the PPM team, Customers and Suppliers.

  • Work with facilities, operations, engineering, purchasing, etc. in the development, execution and change control of validation protocols.

  • Maintain up-to-date knowledge of validation requirements, practices, and procedures.

  • Coach other members of the team participating in validation activities.

  • Support continuous improvement and lean initiatives to identify and drive out waste from current manufacturing processes while maintaining the highest level of quality.

Required Qualifications :

  • BS in Mechanical Engineering or equivalent, Master’s degree a plus.

  • Minimum of 3 years’ experience writing and executing validation documents, IQ/OQ/PQ protocols.

  • Familiarity with Good Manufacturing Practices, as well as Lean Manufacturing/Six Sigma.

  • Experience with both conventional CNC and robotic manufacturing processes.

  • Good understanding of measurement system analysis including GR&R.

  • Ability to use statistical techniques using MiniTab

  • Formal Six Sigma training, Green or Black belt certification a plus.

  • Previous experience working in a highly regulated environment is a must.

  • Understanding of ISO 13485 and FDA 21 CFR part 820 preferred.

  • Ability to generate technical detailed written reports as required.

  • Excellent organizational skills, with the ability to handle multiple priorities and deadlines.

  • Proficiency with various software programs; including word processing, spreadsheet and database applications.

Contact: Bill Zukowsky

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