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Senior Validation Engineer

Company: Actalent
Location: Arcadia
Posted on: September 17, 2022

Job Description:

Description:--- Lead and support GMP validation projects of medium to high complexity (equipment, computerized systems, utilities, facilities, processes, temperature mapping, etc.) alongside in-house and contracted resources--- Develop qualification and validation protocols, execute the associated studies, analyze the resulting data, and develop the final report--- Serve as Validation SME for validation project scopes, approaches, and rationales--- Develop Standard Operating Procedures to develop and mature the Validation program--- Support validation deviation investigations and determine assignable cause alongside Validation Lead and contractors--- Review validation lifecycle documentation, including requirements, specifications, protocols, and reports--- Act as validation signatory representative to approve validation documentation, accountable to management and regulatory agencies--- Support the Validation Team in any required activities to support the development, execution, or improvement of the Validation program--- Understand the application of Data Integrity per 21 CFR Part 11--- Experience and familiarity with the application of FDA, GLP, QSR, and cGMP regulationsAdditional Skills & Qualifications:EDUCATION--- A Bachelor's degree in Life Sciences or Engineering.EXPERIENCE--- A minimum of 5-7+ years of relevant Validation experience (Pharmaceutical, Life Sciences industry cGMP environment)--- Equipment qualification experience in a cGMP environment (IQ, OQ, PQ)--- Strong understanding of the validation lifecycle in GMP settings--- Knowledge of cGMP, GAMP, 21CFR part 11, GDP--- Knowledge of pharmaceutical, manufacturing, and laboratory systems and equipment--- Experience in the qualification of cell therapy equipment is a plus--- Understanding of cGMP regulations, preferably with cell and gene therapy is a plus

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Arcadia , Senior Validation Engineer, Engineering , Arcadia, California

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