Validation Engineer IV - Global Biologics Operations

Expiring today

Employer
JobLeads
Location
Gaithersburg, MD
Posted
Jul 13, 2018
Closes
Jul 16, 2018
Industry
Engineering
Hours
Full Time
At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people's exceptional skills with those of people from all over the globe., Our North America Commercial Headquarters are in Wilmington, DE, and one of our three core global R&D centers is in Gaithersburg, MD. Gaithersburg is also home to MedImmune, the global biologics research and development arm of AstraZeneca. We have a number of other R&D, manufacturing and office locations across the country. The Validation Engineer IV may write validation protocols and reports. Perform validation activities. Maintains up-to-date knowledge of validation requirements, practices and procedures. Able to read P&ID, Isometric and "As Built" drawings. Must be proficient in the use of the Kaye Validator, ValProbe or equivalent. Write validation master plans related to specific projects and coordinate project meetings related to execution of the validation master plan. Write validation site specific and multi-site procedures. Support implementation of validated systems change requests and resolution of process deviations through technical knowledge, execution of supporting validation studies and manufacturing documentation review and approval. Write summaries for regulatory submissions. May travel internationally. Represent company at vendor locations., * Write validation protocols and reports * Perform and execute validation activities described in validation protocols including thermal studies, cleaning verification, process, methods, equipment and utilities validation and qualification and computerized systems (automation and process equipment) qualification. * Maintain an up-to-date knowledge of validation requirements, practices and procedures * Work with validation and metrology contractors when required * Interact with manufacturing sciences, laboratories and facilities / engineering departments to facilitate protocol execution as necessary * Write validation master plans related to specific projects and coordinate project meetings related to execution of the validation master plan * Write validation site specific and multi-site procedures * Support implementation of validated system change requests and resolution of process deviations through technical knowledge, execution of supporting validation studies, and manufacturing documentation review and approval * Develop project plans to ensure validation and qualification executions can be closed on a timely manner * Good technical writing skills * Able to read P&ID, Isometric and "As Built" drawings * Communicate effectively with supervisor and other departments workload, priorities, and issues to maintain validation schedule, * Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy, in meeting objectives. Impact * Contributes to the completion of specific programs and projects. Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources. Liaison * Frequent inter-organizational and outside customer contacts. * Project management experience with facilities upgrades and major construction projects * Experience performing IQ/OQ on large automated systems / process equipment and the computerized system lifecycle associated with it * FAT experience with large automated systems * Cleaning validation and verification * Sterility validation, medial fill * Setting validation specifications for purchasing capital equipment * Shipping validation and verification * Process Validation of biological process * Filter and method validation Knowledge * Complete understanding and wide application of technical principles, theories and concepts in the field. General knowledge of other related disciplines. Problem Solving * Provides technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable and consistent with organizational objectives., * 8+ Years Experience * Lean, project management and risk management experience is desirable

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