Our Client, a leader in rapid point-of-care diagnostics is seeking a Validation Engineers (I, II, or III).
This position is responsible for ensuring validations are addressed according to the QMS, Validation Plan, GMP, ISO and current applicable regulations and guidelines Provides support for process validation including new product development and legacy product manufacturing.
Tasks and responsibilities:
- Provide technical expertise and guidance for the preparation and execution of validation protocols and reports.
- Review and investigate anomalies, deviations, etc.
- Gather data and perform analysis.
- Resolves and consults on applicable validation compliance and manufacturing process issues.
- Perform technical and validation compliance reviews for protocols and reports.
- Contribute at the project team level for validation activities.
- Lead training for execution of validation protocols, and technical training as needed.
- Mentor and lead projects.
- Carries out duties in compliance with established business policies.
- Demonstrates commitment to the development, implementation and effectiveness of Quality Management System per ISO, FDA, and other regulatory agencies.
- Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
- Perform other duties & projects as assigned.
- Understands and is aware of the quality consequences which may occur from the improper performance of their specific job. Has awareness of device defects that may occur in their area of responsibility, including product design, verification and validation, manufacturing and testing activities.
- BS degree or equivalent in engineering or related field.
- 0-3 years of experience for Validation Engineer I
- 5-7 years of experience for Validation Engineer II
- 10+ years of experience for Validation Engineer III
- Exposure to validation of in-vitro diagnostic device and medical device manufacturing processes.
- Knowledge of analytical and physical test methods and their respective validations.
- Comprehensive knowledge of validation documentation.
- Knowledge of federal and other regulations governing medical device assembly and design, e.g. GDP, GMP, QSR, ISO and CMDR.
- Able to work with a variety of people on multiple projects.
- Demonstrate problem-solving and troubleshooting skills
- Strong verbal and written communication skills
- Organized and detail oriented
- Knowledge and ability to use MS Office and other manufacturing systems.
- Knowledge and ability to use JMP or Minitab.
- Ability to work in a cross-functional team environment.