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