What are the responsibilities and job description for the Validation Engineer position at Medefil, Inc.?
• Schedules and executes equipment requalifications per Standard Operating Procedures (SOPs). Coordinates and communicates all testing with affected functional groups and evaluates test results.
• Analyzes data, composes a final report and circulates for approval. Executes equipment validation studies to include protocol preparation, scheduling, protocol execution, and final report preparation.
• Participates in presentation of results to Regulatory Agency when necessary. Programs and operates department analytical instruments (such as temperature/humidity data loggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
• Participates in developments/ improvements to validation programs as needed to remain current with cGMPs and industry standards.
• Participates in teams assembled to install, validate, troubleshoot and maintain systems and equipment.
• Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA).
• Maintain compliance to the validation department operating policies, procedures and validation / qualification protocols; as well as, the requirements and/or guidelines specified by FDA, OSHA and other governmental agencies.
• Maintain the Validation Master Plan (VMP). Administer, create and execution of protocols for new and existing equipment, facilities and process qualification, including IQ, OQ, PQ and requalification.
• Monitor workload schedules to optimize efficiency and Validation simplification, and ensure compliance with project schedules, cost and quality.
• Preparation of supporting validation documents to support ISO, QSR standards; i.e., Functional Specifications (FS), Functional Risk Assessment (FRA), Good Automation Manufacturing Practices (GAMP), GxP Assessment, Qualification Strategy Document (QSD), User Requirement Specification (URS) and Factory Acceptance Testing (FAT).
• Coordinate generation and completion of any deviations, equipment and document change control resulting from a qualification and /or validation activity.
• Write new, revise existing and implement required validation SOPs.
• Maintain the equipment, facility and process requalification plan / schedule.
• Responsible for completing investigation reports related to NOE, OOS events related to equipment, facility and process validations.
• Participate in design reviews
• Have an understanding of PLCs HMIs, Robots, and Vison systems pertaining to validation activities.
• Communicate ideas and comprehend information both verbal and in written form.
• Make recommendations for quality and cost improvements.
Education Minimum / Recommended:
• Degree in Engineering or equivalent in a related field.
Work Experience Required:
• 3 -5 years related pharmaceutical / medical device experience