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The Validation Engineer 2 has primary responsibility for driving overall quality performance and compliance throughout the organization by defining, implementing and maintaining the validation program.
All About You
- Develop and execute IQ, OQ and PQ protocols for product, processes, facilities, software and equipment within the facility.
- Contribute and help write procedures for the Calibration and Environmental Monitoring program sustaining activities.
- Write reports summarizing results and statistics for all equipment, product, or process validation projects.
- Monitor and drive corrective action and continuous improvement activities that directly impact performance measures.
- Provide day-to-day support to development, engineering and manufacturing for design control planning and design transfer activities.
- Work with end users and process owners to collect data to support protocol requirements, analyze data collected and create validation reports.
- Coordinate with end users and process owners to lead development of validation protocols.
- Learn and understand the applicable technology and engage in technical discussions.
- Identify areas and opportunities to improve manufacturing facilities, processes and equipment.
- Provide consultation to other departments performing validation activities
- Ensure validation program meets requirements of FDA and ISO
- Experience in the biotech consumables, medical device/IVD industry in the development and deployment of Quality Systems, and process controls, and continuous improvement methods.
- 1-3 years in manufacturing/quality assurance engineering experience in and FDA regulated environment.
- Knowledge and working application of FDA, and cGMP requirements.
- Intermediate knowledge and working application of Validation Principles and guidelines and industry practice.
- Knowledge in Calibration and Environmental Monitoring Programs.
- Knowledge and working application of standard operating procedures.
- Demonstrated ability to accomplish goals while working across departments is required.
- Ability to multi-task and methodically manage projects.
- Demonstrated strong analytical problem solving (CAPA), team and communications/interpersonal skills.
- Computer competency in MS Office.
- BS Degree in Engineering or Science and/or a minimum of 3 years of related experience
EOE / Minorities / Females / Veterans / Disabled