Validation Engineer - Katalyst Healthcares & Life Sciences

Responsibilities:

• Work under the direction of the Validation Lead and/or function as the validation lead for a project team. The Validation Engineer will be required to support multiple projects simultaneously.
• Develop and execute IQ, OQ, and PQ protocols for products, processes, facilities, software, and equipment within the facility.
• Experience authoring Validation Plan documents, User Requirements, Traceability Matrix, and Validation Summary Reports.
• Write reports summarizing results and statistics for all equipment, products, or process validation projects.
• 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 the 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 the validation program meets FDA and Site-Specific requirements.

Requirements:

• Bachelor's degree in engineering or science and 2-5 years of related experience is required.
• 2+ years' experience in the biotech, pharmaceutical, or medical device industry in developing and deploying Quality Systems, process controls, and continuous improvement methods.
• Must have validation experience of GMP IT or Automation Systems, (2+ years preferred).
• Test protocol or test script authoring.
• Test execution.
• Documentation of failures or non-conformances.
• Resolution of failures or non-conformances.
• Familiarity with electronic validation/QMS systems such as Veeva, Master Control, Valgenesis, Service Now, or KNEET.
• 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.
• Ability to multi-task and methodically manage projects.
• Demonstrated ability to accomplish goals while working across departments is required.
• Demonstrated strong analytical problem-solving, team, and communications/interpersonal skills.