Validation Engineer

Responsibilities

Validation Engineer is needed to perform the following duties:

• Design, develop and optimize process simulation techniques for process optimization and scale up for large scale commercial product manufacturing.
• Lead projects by use of appropriate project management tools; provide timely updates to management on the status of various projects.
• Experience in Validation of Warehouse and/or Controlled Temperature Units (freezers, Fridges, etc).
• Perform hands on execution of validation testing on Controlled temperature units, and computer systems.
• Provide knowledge and experience in the application of experimental design concepts to process development optimization and robustness studies.
• Develop acceptance criteria consistent with industry standards, manufacturer recommendations, user and functional specifications, and current Good Manufacturing Practices (cGMP).
• Perform continuous improvements by developing best and proven practices in the department based upon current industry standards.
• Participate in the risk assessment related to the project and guide the team in risk management approaches and systems. Make or escalates decisions regarding the appropriate risk when there is substantial project impact.
• Manage and perform the development of validation protocols, the development of validation studies, data analysis, and compilation of the data and results into final reports in GMP compliant formats.
• Perform Pre- and Post- calibration of thermocouples, temperature mapping on Control Temperature Units.
• Review all related protocols and C&Q Plans, determine the validation approach, the required qualifications, the sampling plan, and ensure the follow-up and tracking of the validation's activities of the group.
• Track status of all deliverables and provide management updates, Meet required quality system and project timelines.
• Provide validation expertise for the development (or modification phases) of manufacturing facility, systems, process and information and Computerized System; address, include and implement all the applicable QA requirements.
• Author Validation protocols, standard operating procedures (SOPs), Validation reports incorporating ALCOA principles etc., in adherence to company guidelines as recommended by USFDA.
• Lead problem solving for technical manufacturing issues, applying learnings to drive continuous improvement and enhancing standards.
• Use project management skills to oversee all phases of engineering change management including Change Control for owned changes and ensure completion of deliverables including design and testing documentation.
• Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable, and operation of the system.
• Support all phases of engineering project implementation to meet scope, schedule, budget, quality, and safety requirements while adhering to all company policies and safety protocols.