93 applicants

Company

Original Job Post

AstraZeneca · 2 days ago

Validation Engineer III

US - Gaithersburg - MD

Full-time

Onsite

Senior Level

5+ years exp

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BiopharmaBiotechnology

Comp. & Benefits

Insider Connection @AstraZeneca

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Responsibilities

Provide oversight on site validation programs.

Review and approve validation protocols and reports.

Maintain an up-to-date knowledge of validation requirements, practices and procedures.

Partner with Site Validation, Manufacturing Sciences and Facilities / Engineering departments to facilitate qualifications and validations.

Manage multiple projects concurrently, contribute to the completion of milestones associated with projects and Quality Records.

Perform Gap assessments to align local procedures to global AZ standards.

Qualification

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ValidationBiopharmaceutical industryPharmaceutical industryIO/OQ/PQEquipment/system validationComputer skillsMicrosoft OfficeCommunicationCollaborationData Integrity RegulationAutomated System QualificationCleaning ValidationSterility ValidationValidation RoleComputer System ValidationQuality AssuranceVeeva Electronic QualityDocumentation Systems

Required

B.S. in Engineering or Technical Field

Minimum of Five (5) years’ experience in validation within biopharmaceutical/pharmaceutical industry

Experience performing IO/OQ/PQ on various types of equipment/system

Effective written and oral communication skills to explain, influence, and collaborate on major initiatives

Proficient computer skills including Microsoft Office applications

Preferred

Experience with Data Integrity regulation and application preferred

Experience in performing large automated system qualification, cleaning validation and/or sterility validation desirable

Experience in a validation role (computer system validation)

Quality Assurance experience

Experience with Veeva electronic Quality and documentation systems

Company

AstraZeneca

Glassdoor

4.1

AstraZeneca is a pharmaceutical company that discovers, develops, manufactures, and markets prescription medicines. It is a sub-organization of Investor AB.

Founded in 1999

Cambridge, Cambridgeshire, GBR

10,001+ employees