Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
Job Description:
The Validation Engineer is responsible for developing DQ/IQ/OQ/PQ protocols and coordinating and performing equipment qualifications, ensuring that automated process equipment that mass produce medical device consumables and other products, are designed, developed or changed in compliance with specifications, requirements, safety and Company and regulatory guidelines. The Validation Engineer will work closely with Senior validation staff, maintenance, operations, and R&D teams to create and document procedures to validate products and processes, which may include elements of verification and sub-system tests as well as other validation efforts.
Responsibilities:
Assists in authoring validation/qualification protocols, including Design Qualification/Installation Qualification/Operational Qualification/Performance Qualification (DQ/IQ/OQ/PQ).
Execute validation/qualification protocols for processes, equipment, facilities, and utility systems.
Prepare validation/qualification summary reports for the executed protocols.
Support continuous improvement and CAPA (corrective action/preventive action) activities related to validation.
Contribute to the generation and review of required documentation (SOP’s, Protocols, Change Requests/Change Controls) to support validation activities.
Monitor ongoing design efforts to determine and communicate validation tests, protocols, and standards. Propose design solutions that enable and facilitate validation efforts. Serve as quality systems expert on cross functional teams during new equipment design phase. Define test plans during the product development process so that the validation test plans are known in advance.
Ensure protocols, records, and procedures are in compliance with current Good Manufacturing Practices (cGMP), industry standards and approved SOPs.
Other duties as assigned.
Requirements:
Bachelor’s degree in science/engineering or related Life Science.
Ability to quickly learn new technologies and applications as necessary to understand validation requirements.
Prior work experience in FDA regulated environment preferred.
Working knowledge of quality tools helpful, including statistical techniques, technical writing, metrology and calibration, inspection and testing, Statistical Process Control (SPC), Failure Mode and Effects Analysis (FMEA), sampling principles and Acceptable Quality Level (AQL), process mapping, risk analysis, cause and effect diagrams and Pareto analysis.
Excellent problem solving (Six Sigma), root cause analysis, and process improvement skills with automated manufacturing and process control equipment.
Highly proficient in Windows MS Office (Excel, Word, Outlook, PowerPoint, Teams) applications.