Quality Process Engineer - Operations
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 exceptional skills with those of people from all over the globe.
The Quality Process Engineer will be responsible for the design, installation, commissioning startup and validation of manufacturing systems and processes and products and facilities at the Coppell, Texas site.
Responsibilities / tasks include but are not limited to:
Skills & Qualifications:
- Identify potential sources of variation in materials, processes, facilities, equipment, and products that may impact consistent performance or product quality.
- Evaluate equipment and processes and identify potential critical parameters based upon possible impact on product quality attributes.
- Prepare and perform qualification, requalification, and process validation protocols, analyze collected data against pre-determined criteria, and prepare final reports in compliance with relevant regulations, industry practices, and AstraZeneca policies and procedures.
- Perform and document field verification of equipment, instruments, and facilities as required by approved protocols.
- Perform and/or review risk assessments for instruments, equipment, processes, and products.
- Analyze data and information to determine whether processes, equipment, and products are within an appropriate state of control during qualification and validation as well as in assessing the need for requalification / revalidation on a periodic basis.
- Prepare, document, and/or evaluate change controls to ensure that equipment, products, processes, and facilities remain in qualified, validated state.
- Identify and investigate unusual or unexpected events, data, or sources of variation during the development and performance of qualifications/validations; assess and recommend disposition regarding the impact upon qualification or validation as applicable, and recommend appropriate corrective/preventive actions.
- Ensure that work is performed in accordance with applicable regulations, industry guidelines and practices, approved procedures and cGMP.
- Other responsibilities as assigned by department management.
Education and Experience:
- Bachelor’s degree required, preferred in engineering field and three (3) years experience in pharmaceutical or related industry.
- Demonstrated understanding of process design, qualification and validation concepts, including the capability to assess processes, equipment, and products for sources of variation, ability to analyze data against predefined criteria and reach appropriate conclusions.
- Must have attention to detail. Work requires a high degree of accuracy in complex documentation.
- Must understand concepts of qualification and validation as well as sampling, risk evaluation, and detection of variation.
- Awareness of qualification of control systems and computer system validation (CSV) preferred.
- Able to work cooperatively with other members of the Validation Team, Quality, and Manufacturing in the design and performance of qualification and validations.
- Must effectively evaluate information collected from various sources and determine impact upon controlled state of processes, equipment, facilities, and products.
- Excellent technical writing and verbal communication skills
- Knowledge of and ability to read P&IDs and other technical information and incorporate into user, facility, and equipment specifications helpful.
- Requires the ability to apply scientific and analytical principles for solving problems and proper design of qualifications and validations.
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.