Specialist

R&D Senior Quality Specialist (Validation), Abb Vie Inc., Irvine, California. Support the qualification and requalification of equipment and instrumentation, including computerized systems, used within the R&D laboratory function associated with FDA Good Manufacturing Practices (GMP) testing for biological and small molecule projects. Responsible for the planning, design and implementation of validation projects, coordination of validation activities, and preparation of validation documentation within Pharmaceutical Development, with established guidelines for pharmaceutical products manufactured in a GMP environment. Utilize knowledge of GMP concepts relating to Pharmaceutical manufacturing environment to plan, develop, organize, and execute validation activities applicable to area of technical expertise in accordance with GMP, ISO 9000, ICH, and applicable guidelines including project management, validation documentation generation, and project tracking. Maintain project deadlines and communicate validation activities with appropriate personnel in a timely manner. Define, author, organize, and review validation documentation, SOPs, and forms. Must possess a Bachelors in Engineering, Microbiology or Chemistry, or a related field, and at least 5 years of work experience performing GMP validation. Of experience required, must have 3 years of work experience: (i) Performing laboratory instrumentation validation, temperature mapping of environmental chambers, & sterilization validation (autoclaves); (ii) Project coordination involving third-party validation vendor management; (iii) Utilizing validation principles and techniques including validation of pharmaceutical processes, facilities/utilities, manufacturing & laboratory equipment; & (iv) Applying GMP concepts relating to pharmaceutical manufacturing environment & validation activities. Experience must be gained concurrently. Apply online at https://careers.abbvie.com/en or send resume to Job.opportunity.abbvie@abbvie.com. Refer to Req ID: REF35111G. Salary Range: $124,920.26 - $157,500.00 per year.

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