Senior Automation Engineer

Accountabilities
• Ethical conduct and compliance: Assure compliance of self and team to internal and external regulations.
• Fiscal and financial control: Follow AZ’s financial policies, handle requests for project and support resources to policy requirements, and lead small capital projects following standard Project Management Framework.
• Leadership and engagement: Understand the big picture and connect individuals to it in a meaningful way. Understand the end picture of the developed control systems and interactions between all groups.
• Compliance: Ensure compliance is understood and maintained across your functional area. Ensure that the required initial and continuing training of department personnel is carried out and adapted according to need.
• Continuous improvement: Strive to continuously improve established processes for achieving high-quality support for operation and manufacture of Lokelma.
• Essential Functions: Lead the design, implementation, and support of site-wide process automation, SCADA solutions, including programming PLC/HMI code, batch subsystems, historian subsystems, and collaborating with MES or corporate enterprise systems. Review and approve requirements, specifications, drawings, coding procedures, and guidelines. Lead solving activities, train others on systems, software, equipment, machines, procedures, and processes. Use CMMS to handle logistics. Communicate priorities and progress to the team. Analyze data trends to provide accurate descriptions, identify root causes, and propose solutions or improvements. Provide containment actions and permanent improvements to identified problems. Oversee key performance indicators to meet strategic goals. Write, review, and revise SOPs for equipment maintenance, systems, and facilities. Connect with other departments to implement corrective/preventative actions. Author, review, and approve minor change records and site change controls. Align with cGMP and SOPs. Perform preventative and corrective maintenance of equipment without supervision. Ensure accurate documentation practices during maintenance processes. Read and interpret diagrams, drawings, and schematics. Recommend activities to ensure area and equipment compliance. Assess and implement efficiency improvements. Assist process engineering and project management teams with improvement projects. Consult cross-functionally as an SME on systems/processes within a functional area. Coordinate third-party personnel activities. Lead investigations with little supervision. Investigate major deviations as a certified Investigator.

Other Duties: Close out deviations, CAPAs, and pAFCAs as needed. Develop lean processes and procedures. Initiate appropriate action when process deviations occur. Interact with regulatory agency personnel during audits/inspections. Monitor records for regulatory compliance. Perform quality audits on devices. Author new SOPs and improve existing ones. Monitor equipment/systems for performance indicators. Perform data entry. Report process deviations. Wear gowning/PPE as required. Develop validation protocols for control system changes. Assist with executing validation protocols for processes/equipment/cleaning. Conduct presentations for different audiences. Create equipment specifications. Evaluate new software/tools. Handle capital projects for timely/budget completion. Maintain archived records/documentation. Run supplier activities during design/fabrication/installation/commissioning/qualification. Perform factory acceptance tests. Provide 24/7 "on-call" support.

Essential Skills/Experience
• Bachelor’s Degree in Engineering, Computer Science or related field
• > 5 years experience in Pharmaceutical and Biologics regulated manufacturing operation in a regulated or cGMP environment
• Knowledge of process and utility design, operation and maintenance
• Thorough understanding of GMP related to Facility design and operation
• Knowledgeable about Rockwell Automation controls systems
• Strong Problem solving skills

Desirable Skills/Experience
• Experience in automation, SCADA systems, software development
• Solid understanding of IT infrastructure as it relates to an automated system
• Thorough understanding of electrical schematics
• Understanding of Instrumentation and maintenance of equipment used in automated systems
• Lean Leadership skills and application in a GxP environment

At AstraZeneca, we are breaking new ground with opportunities to evolve our Supply Chain while crafting a collective legacy! We are leaders in this space with balanced lifecycle management practices that ensure we do things the right way. This is your chance to take ownership and reshape the entire ecosystem from technological advances to developing more ethical approaches.

Ready to make a significant impact? Apply now!

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.