Validation Engineer - Redwood City, CA
Do you possess sustaining engineering experience and are passionate about building a huge impact within a large pharmaceutical company's smaller test manufacturing site for novel drugs and treatments? If so, then this is the role for you!
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 outstanding skills with those of people from all over the globe.
In 2013, AstraZeneca acquired Pearl to expand and strengthen its respiratory products portfolio, We have made strides in bringing therapies to asthma patients. Our mission and vision are to develop differentiated therapeutics for widely prevalent respiratory disease conditions, including chronic obstructive pulmonary disease (COPD), by utilizing a proprietary drug delivery platform and existing therapeutic agents administered in metered-dose inhalers (MDIs).
As a Validation Engineer, you will be responsible for performing qualification and validation of equipment, processes, facilities, utilities, automation, and Computerized systems to support site goals and targets.
What you'll do:
- Performs installation and operational and performance qualification (IQ/OQ/PQ) of manufacturing equipment, facilities, utility, automated and Computerized systems. Responsibilities include newly installed equipment and systems as well as previously qualified equipment and systems, which are modified through Change Control and periodic reviews of equipment, facilities, and utility systems.
- Develops and reviews qualification protocols and reports, coordinates system and equipment documentation collection, and analyze collected data against pre-determined criteria.
- Solves qualification and validation execution issues using critical analysis skills and develops sound, reasoned solutions and recommendations.
- Perform and/or review risk assessments for instrument, equipment, processes, utilities and facilities.
- Works with Operating Technicians and Maintenance during fieldwork and execution of protocols.
- Represents the Validation group in Change Control meetings and evaluates impact of changes to the validated state.
- Ensure that work is performed in accordance with applicable laws, industry guidelines and practices, approved procedures and cGMP.
- Performs assessments to determine if re-qualification and/or re-validation is needed in accordance with local procedures.
- Maintains and improves reliable and adaptable working relationships with internal and external customers and suppliers.
- Bachelor's degree in a science, technical or engineering field
- Minimum of 1 year experience in qualification or validation in the pharmaceutical industry or related work experience from scientific or technical degree.
- Excellent technical writing, verbal communication skills, and collaboration skills
- Requires the ability to analyze data and apply scientific principles for solving problems
- Awareness of qualification of control systems and computer system validation
- Knowledge of and ability to read P&IDs and other technical information and incorporate into user, facility, and equipment specifications
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being ambitious - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, groundbreaking cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
Are you already imagining yourself joining our team? Good, because we can't wait to hear from you!Find out more on Social Media:
About Operations https://www.youtube.com/watch?v=gak5Ham8oUw
US based Employees: AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants. COVID-19 vaccination is required for all US employees. Individuals who are unable to receive a COVID-19 vaccine based on applicable law, such as medical and religious reasons, can submit a request for a reasonable accommodation. For employees who are not vaccinated and who are granted an exemption to the vaccine requirement for qualifying reasons, the primary accommodation will remain weekly COVID-19 PCR testing.
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