AstraZeneca Pharmaceuticals LP Validation Engineer / Sr. Validation Engineer - Mount Vernon, IN - Global Operations in Mount Vernon, Indiana
The Validation Engineer performs installation and operational and performance qualification
(IQ/OQ/PQ) of critical manufacturing equipment, facilities, and utility systems for the site. Performs cleaning validation activities for new products and maintains existing products. The Validation Engineer provides technical support for process manufacturing and packaging including investigations and correction of cleaning process-related problems and deviations from standards.
Performs installation and operational and performance qualification (IQ/OQ/PQ) of critical manufacturing equipment, facilities, and utility systems. Responsibilities include newly installed equipment and systems as well as previously qualified equipment and systems, which are modified through Change Control and periodic assessments of equipment, facilities, and utility systems.
Develops and reviews qualification protocols and reports, coordinates system and equipment documentation collection, and executes protocols.
Develops and reviews cleaning validation protocols and reports, coordinates room and equipment documentation collection, and executes protocols.
Solves qualification and cleaning validation execution issues using critical analysis skills and develops sound, reasoned solutions and recommendations.
Works with Operating Technicians and Maintenance during fieldwork and execution of protocols.
Oversees capital qualification services related to Formulation and/or Packaging and performs peer review of contract/consulting documentation.
Performs fieldwork such as checking systems and equipment that are located in manufacturing areas, on mezzanines and rooftops, and in mechanical spaces or penthouses.
Represents the Validation group in Change Control meetings and in Departmental qualifications and cleaning validation discussions.
Verifies red-line drawings to “as-built” status.
Performs assessments to determine if re-qualification and/or re-validation is needed in accordance with local procedures.
Maintains and enhances reliable and responsive working relationships with internal and external customers and suppliers.
Participates in the validation activities associated with all Quality Investigations.
- Bachelor’s degree required, preferably in Engineering, Chemistry, Biology, or Pharmaceutical Sciences.
Minimum of 0-3 years of relevant validation experience in the pharmaceutical industry.
A combination of education and relevant experience will be considered.
Experience in conceptual development, project management (planning and scheduling projects), design, and implementation of major capital projects.
Knowledge and understanding of validation and qualification principles, project management, and change control principles.
Demonstrated ability to effectively communicate and collaborate across all levels of the organization including with customers, vendors, equipment suppliers, and Operations staff.
Six Sigma green belt or equivalent experience is preferred.
Experience with IQ/OQ/PQ, Cleaning Validation, and Lean Manufacturing is highly desirable.
Experience in the pharmaceutical industry and related regulatory, engineering, and construction techniques is highly desirable.
Next Steps – Apply today!
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AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.