Description

Azzur Group San Francisco is looking for Process Validation Engineer to join our growing San Francisco team. Working with a multi-disciplinary team, the process validation engineer ensures fulfillment of process characterization for our client according to the established plan. In this hands-on role, the process validation engineer is responsible for the quality of work produced by the process validation team. Experience with cGMP and FDA compliance is essential.

 

Essential Duties and Responsibilities

Function as SME and lead technical team on site for late stage to commercial stage recombinant protein drug development for both Drug Substance and Drug Product process validation, including mixing studies, product hold studies, risk assessments, protocol generation and execution for PPQ, and cGMP manufacturing.Provide technical guidance and keep project on time and in compliance with cGMP regulations.Review and approve controlled documents including batch records, SOPs, protocols, and reports related to process validation.Work closely with QA/QC to identify and evaluate deviations, CAPA and change control.Ensure compliance with both internal client’s process and policy and with regional regulatory requirements all with a focus on quality and accuracy in verbal and written communication.Responsible for assigned project/timeline planning and tracking of commitments. Responsible for communication of commitments to team members.

 

Required Experience

BS Engineering or related discipline.6-10 years process validation engineering experience in the pharmaceutical and/or biotechnology industry is required.Experience with FDA compliance and cGMP is required.Must be results oriented with several years of hands-on experience, familiar with industry concepts, practices and procedures in a cGMP environment.Must have experience executing PPQExcellent verbal, oral, and technical writing communication skills.Proficient in Microsoft Word, Excel, Power Point, and able to quickly learn new computer applications.

Azzur Core Values:

Puts Others First...Have the Courage to Take Action…Take Personal Responsibilities…Have Fun!

 

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