AstraZeneca Pharmaceuticals LP Validation Engineer IV - Global Biologics Operations in Gaithersburg, Maryland
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.
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
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
- Complete understanding and wide application of technical principles, theories and concepts in the field. General knowledge of other related disciplines.
- Provides technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable and consistent with organizational objectives.
Discretion / Latitude
- Works under only general direction. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy, in meeting objectives.
- 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.
- Frequent inter-organizational and outside customer contacts.
8+ Years Experience
Lean, project management and risk management experience is 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. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.