Associate Director, Validation

2 weeks ago

Rockville, United States Workday Full time

Are you ready to break new ground and leave a collective legacy? As an Associate Director of Validation at AstraZeneca, you are expected to have a complete understanding and be responsible for a wide application of technical principles, theories, and concepts in the field of Validation. You must be able to solve practical problems and deal with various concrete variables in situations where only limited standardization exists.What youll do:Own and maintain a robust qualification and quality program to support and maintain a qualified and compliant state facility, including processes, laboratories, and utility equipment.Support Computerized System Validation (CSV) documents including Risk assessments, validation project plans, User Acceptance tests, and reports.Responsible for supporting/ leading investigation, implementation of corrective actions (CAPA), deviations, and change control for the GMP system.Support process and method transfer validation activities, as necessary by the manufacturing and Quality Controls lab.Be responsible for the Validation Master Plan (VMP) and guide the validation activities including validation maintenance studies, start-up protocols, thermal studies, QC equipment, process equipment, and utilities.Lead a team of Validation engineers while actively handling personnel resources against active and forecasted projects.Assure that facilities, laboratory equipment, utility systems, and process equipment are maintained qualified/validated state and that reports are written accurately and timely.Direct day-to-day operations of validation services in a way that minimizes downtime of manufacturing equipment.Author annual product quality review and ensure validation protocols and processes follow global regulatory requirements.Present overviews and defend site validation programs to regulatory and other agencies as necessary.Implement industry best practices to support site compliance operation and withstand inspection by regulatory agencies.Support implementation of product change requests and approve validation standard operating procedures.Responsible for preparing and handling within the annual budget and project coordination with AstraZeneca staff and/or outside consultants as necessary.Minimum Qualifications:Bachelors Degree. Life Sciences or Engineering Preferred.Minimum of 10 years experience in most of the following areas: FAT, SAT, and commissioning of facility systemsSetting validation specifications for purchasing capital equipment or instrumentsProject management experience with upgrades and major construction projectsPerforming IQ/OQ on, Facilities/Utilities/Equipment Qualification, and Computer systems validation and Environmental Monitoring Performance QualificationMinimum of 3 years of leadership or management experience.Strong leadership skills with the ability to work in a dynamic environment and adapt their style to get along with all levels of management.Excellent project management and technical problem-solving skills. Must possess a passion for continuous improvement in accountable areas.Strong communication skills, both verbal and written.Knowledge of Lean best practices and cGMP.When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. Thats why we work, on average, a minimum of three days per week from the office. But that doesn't mean were not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.Why AstraZeneca?With constant new products and launches, there's never been a better time to join Supply Chain and shape our future with a big contribution to life-changing medicines. The challenge to stay ahead in rapidly changing markets is what keeps us driving forward, as we continuously seek new and better ways to deliver medicines all the way to our patients. Our resilience helps us to thrive as we innovate and evolve.Are you ready to make a big impact? If you are driven, take smart risks, and can act quickly, then this is the place for you. Apply today and join us in our mission to push the boundaries of science and make a differenceDate Posted23-Apr-2024Closing Date06-May-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.#J-18808-Ljbffr

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