Validation Engineer IV, Quality Assurance
Lonza, Inc. Houston, TX
At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia. Our vision: We strive to be the leading supplier using science and technology to improve the quality of life. Our mission: We work with passion, using advanced technologies, to transform life science into new possibilities for our customers. Do you want to help us as we shape the future of this great organization? Job Description Summary Validations Engineer IV, Quality Assurance Support the Validation Supervisor by ensuring effective validations execution and maintenance of manufacturing equipment, facilities and process utilities. Track and report action plan status/ completion as relates to validation systems improvement efforts. Responsible for the development and the execution of qualifications, validations, re-qualifications and re-validation for process equipment, laboratory equipment, utilities and facilities Responsibilities Generates and executes (as applicable) Validation Project Plans, Validation protocols (IQ/OQ/PQ) and summary reports and SOPs as required LONZA site’s Validation Master Plan, SOPs and global policies. Systems include incubators, BSCs, Autoclaves, Bioreactors, process gases, DI water system, Classified Clean Rooms/HVAC (Grades, A through D), among others. Works with Gap Assessments and Remediation Plans with an understanding of applying risk management principles. Able to work independently (author protocol, execute studies, analyze data, author reports). Advanced knowledge of discipline; able to discuss regulatory expectations for validation activities, program and documentation. Able to handle some larger and more complicated project work but with oversight at a moderate degree. Demonstrated ability to plan and organize validation activities among cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work. Capable of independently discussing validation philosophies during customer audits or regulatory inspections in the presence of the Manager. Would be able to correctly answer questions about day-to-day activities that would be most likely posed by Validation Engineer I-III level personnel. Able to correctly assess large and complex change controls with an accurate understanding of the bigger picture implications of changes. May still need some review and oversight or feedback. Technical Knowledge Thorough knowledge of validation life cycle, validation protocols (IQ/OQ/PQ) generation and execution of manufacturing and laboratory equipment, clean process utilities and classified facilities Fundamental understanding of validated computer systems and change management in the commercial pharmaceutical/biotech industry, including training others. GMP compliance knowledge including knowledge of 21 CFR Parts 210, 211, 11, GAMP 5 and ISO 13485:2003 requirements, among others Computer Skills Proficient in the use of spreadsheets, databases, and word processing software. Performs statistical analysis of data. Knowledge of SAP and TrackWise systems a plus Decision Making Uses experience and knowledge to solve problems, make decisions, and develop plans for the group. Makes recommendations for the department. Able to identify and respond to complex problems, interpret complex data and draw valid conclusions. Improves efficiency of self and team by clearly defining and analyzing problems and implementing new ways of approaching work. Planning/Prioritization Demonstrated experience in management of complex tasks and projects. Proficient at establishing clear and understandable directions and goals. Provides and implements suggested resolution to roadblocks. Able to prioritize own work and aid in setting group priorities. Strong organizational skills. Communication Able to write complex procedures and reports. Able to communicate status, needs, forecasts, risks and timelines effectively to management. Communicates expectations effectively to members on project teams and in area. Uses mediation skills to resolve or avoid conflict. Able to prioritize own work and aid in setting group priorities. Strong organizational skills. Education and Experience Required: BS degree or equivalent in technical area preferred. 10- years experience in pharmaceutical, biotechnology, or related industry. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. Lonza. The place to Go, Stay and Grow.