Quality Engineer - Validation

Quality Engineer in ValidationsAs the Quality Engineer in Validations, you will be responsible to complete projects that provide general quality technical support for new and commercial product manufacturing operations and validation testing of production quality systems.Duties/Responsibilities:Essential Functions - These duties are essential to the effective performance of the key functions that are required for this position.Pharmaceutical Production Systems Validation Support.Write validation test protocols and technical reports. Protocols types include Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Process Performance Qualification (PPQ).Perform monitoring, sampling, and testing to validate equipment, systems, and manufacturing/packaging processes per validation test protocols.Drives Process Validation Program (Process and Equipment) including Continued Process Verification (Stages 2 and 3 of 2011 FDA Guidance on Process Validation).Drives Cleaning Validation and Verification Program.Drives Computerized Systems Validation Program including 21 CFR Part 11 compliance and data integrity risk assessments.Interacts directly with customer on deviations and Cleaning and process validation strategy for assigned projects.Reviews and validates Electronic Speadsheets.Assess regulatory impact of deviations, changes to equipment and batch records, materials and calibrations from a validation perspective.Analyze validation test data to provide statistical conclusions and recommendations to customers.Coordinate validation activities with other functional groups and customers to complete them according to the established project timeline.Provide research and background support data for equipment, systems, and processes to be validated.Write manufacturing process project plans and summary reports.Provide impact assessments for any changes made to validated equipment, systems, and processes; and execute any identified revalidation actions to maintain the validated status.Participate in the collection and analysis of process performance trend data of validated manufacturing/packaging processes.Validation Technical SupportSupport corporate scientific studies and analysis to investigate exception occurrences, atypical observations, customer complaints, and CAPA events.Provide validation technical support review for the design and development activities for new or transferred manufacturing/packaging processes.Support actions can include technical support in creating process master batch records, contributing in process and contamination control risk assessments, and participating in equipment and process design reviews.Providing validation technical support to the qualification of new facilities, utilities, and processing equipment.Support actions can include contributions to define equipment user requirements, review and assistance in generating and executing factory acceptance testing (FAT) and site acceptance testing (SAT) actions and generating IQ/OQ/PQ test protocols.Review cleaning validation test protocols, reports, risk assessments, and support documentation for acceptable validation strategy and compliance with FDA cleaning validation guidelines.Provide validation subject matter expert support in answering questions for project management projects, customer queries, and audits.Knowledge and Abilities:Knowledge of manufacturing equipment and processes. Working knowledge of cGMP, ISO, ISPE, ANSI/ASQ standards and guidelines. Ability to observe and understand cause/effect phenomena and apply scientific methods to gain technical information and solve problems. Ability to systematically collate, organize, and interpret data, as well as to derive problematic solutions from observed data. Basic working knowledge of ISPE GAMP 5 guideline concepts for GxP computerized system. Working knowledge of risk management and risk management tools and their applications. Ability to work with minimal supervision and to prioritize project work activities.Education and Experience:Bachelor's degree in engineering or life science fields OR 2 years of college or vocational education (preferably in engineering or life science fields) with 2-5 years of experience in the pharmaceutical and/or medical device industries. 2 to 5 years experience in the pharmaceutical and/or medical device industries.