AstraZeneca hires people with a passion to make a difference in the health of millions of people globally. Your expertise, coupled with AZ's advanced technologies and collaboration with thousands of innovative scientists, chemists, and analysts will help bring life-enhancing products to the people you know and love. Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better and healthier. Interested in learning more about life at AstraZeneca, a world-leading pharmaceutical company? Start here.
Job Summary In this detail-oriented role, the Empower Support Engineer must be knowledgeable with the use of chromatography systems in an FDA-regulated environment and the industry best practices for validating the system. Experience with Empower or other lab-based applications is required. The candidate is expected to be a collaborative team member in supporting and maintaining the business-critical application. The candidate should possess broad functional knowledge in his/her domain and in-depth technical knowledge in Water's CDS System.
The main responsibilities of the role: Ensure optimum performance and stability for Quality Chromatography system Global Empower and other lab-based applications.Provide 2nd/3rd line support (technical queries, bug fixes, and small enhancements relating to application and platform), complying with ITIL standards and change control procedures.Take ownership of issues through delivery or issue resolution or escalation, as appropriate.Work on Empower project creation, project archival, and restoration.Perform SQT for LACE's.Integrate chromatography data systems to third-party software and HPLC, UPLC, and GC systems.Analyze errors and warning messages in the instrument through the application.Execute manual backup/restoration and disaster recovery procedures.Configure various laboratory systems to Empower Application.Gain hands-on experience in Empower Version Migration activities.Gain hands-on experience in Empower message center purging and audit logs investigation.Provide end-to-end support for applications.Develop specialist knowledge in relevant systems, documenting and sharing that knowledge, as required, with global teams.Liaise with multiple stakeholders including users, infrastructure/middleware teams, and third-party software vendors for resolving issues and potential process improvements.Train, guide, and mentor new hires in the team.Work in a DevOps and Agile way.Essential Experience: (Must have skills) Experience in application support and maintenance (L2/L3 support) of off-the-shelf Chromatography Data Systems.Knowledge of Waters Empower CDS, understanding of detection techniques, reporting, custom calculations, metadata, and workflows relating to lab data.Understanding of basic Pro Interface and Advanced Topics (which include method and report templates, custom calculations, dissolution, method validation manager, and system administration).Experience in integrating chromatography data systems to third-party software and HPLC and GC systems.Good knowledge of regulatory requirements including GMP, GxP, and 21 CFR Part 11. Exposure to software system validation in a GxP environment preferred.Experience on Windows/UNIX application environment and understanding of client-server/distributed computing concepts.Basic understanding of session virtualization concepts, exposure to Citrix working environments.Understanding of incident, problem, change, and release management processes.Supplementary Experience: (Useful additional skills) Familiarity with life sciences (Pharma) domain concepts, workflow, and terminology.Good understanding and troubleshooting experience with Microsoft IIS/Web Services (IIS 7.0, IIS 8.0, IIS 8.5).Experience working with tools like SQL Developer, MS SQL Server Management, and ALM.Experience in setting up and managing application environments.Mindset to support business-critical applications.Experience in scripting using PowerShell and Automation.Basic knowledge in Chromatography archival system NuGenesis is an added advantage.Knowledge in working with AWS environment is an added advantage.Exposure to DevOps and Agile ways of working will be preferred.Educational Qualifications UG - B. Tech /B.E. or other equivalent technical qualifications.
Personal Attributes: Keen to acquire new skills and work on new technology products.Must participate in on-call rotation with off-hours support responsibilities.Ability to work independently, as well as in a team environment.Logical mind with keen analytical skills.Clear and concise communicator, both written and verbal.Ability to respond well to pressure.Strong interpersonal skills with the ability to work effectively across team boundaries.Expectation of working in the office 3 days a week: When we put unexpected teams in the same room, we ignite ambitious thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace, and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our outstanding and bold world! AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable), or any other characteristic protected by law.
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