The Computer Validation Engineer II is accountable for execution of computer validation program and lifecycle management of automation systems for AZ Biopharmaceutical Development (BPD) facilities including analytical test laboratories, quality control laboratories, manufacturing facilities and clinical manufacturing facilities.  They help plan and co-ordinate activities within the Engineering function, and may have some supervisory responsibilities for technical staff. Alternatively, they provide technical support and advice to colleagues in area of expertise, applying developed solutions and supporting performance improvement projects whilst adhering to local best practice, safety and compliance standards.

Responsibilities:

• Subject Matter Expert (SME) and system owner for validation of analytical systems
• Accountable for specification, design and lifecycle management of analytical systems.
• Creates standards for analytical computer validation in clinical cGMP testing laboratories.
• Assesses capital equipment design and budgets appropriate resources to the projects.
• Executes validation for manufacturing equipment, analytical equipment, infrastructure, spreadsheets, code changes, etc.
• Executes work in alignment with quality, safety and sustainability standards. 
• Performs project management activities for analytical systems.
• Performs change control 
• Writes user requirements, specifications, test scripts, and recipes

• Provides technical support to team members and other AstraZeneca engineers by using existing knowledge and experience and by seeking out information to resolve standard problems
• Ensures the appropriate allocation of resources by following resource plans and contributing to their development
• Analyses information to identify corrective actions and develop practical solutions, either alone or with the support of a small team
• Participates in activities across Engineering function, helping ensure that agreed priorities are carried out and projects are delivered to plan
• Provides input to continuous improvement activities, conducts root cause analysis and supports new product introduction
• Drafts information for discussion at higher levels within the business, such as analysis to support business case documents, improvement plans, priorities, investigation reports, quality or performance improvement recommendations

Education and Experience Requirements:

• Bachelor’s degree in Engineering, Computer Sciences or an equivalent combination of education and 3-5 years of experience.
• GMP and GDP experience in a biotech or sterile pharmaceutical automation environment
• Validation/Quality review computer systems.
• Knowledge of data integrity regulations including  21CFR part 11 compliance
• Project Management experience

Date Posted

Closing Date

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 authorization and employment eligibility verification requirements.