OverviewThis Is What You Will Do As the ‘MCS Lead Automation Engineer – BDS MCS’, you will oversee the key batch process Manufacturing Control System at College Park. Your role will include ownership of:Manufacturing Control System (MCS): This is the Emerson DeltaV control system integrating with process equipment from Upstream Bioreactors and Media, through Harvest Centrifuge and Filtration, to Downstream Buffer, Chromatography, Ultrafiltration, Viral Inactivation and Viral Filtration through to Final Fill.Sustaining Automation MCS Support: Leadership and oversight to our in-house Automation Manufacturing Control System (MCS) team.You Will Be Responsible ForLeadership and Oversight:Provide main single-point-of-contact for stakeholders for Sustaining Automation (MCS) support for GxP Batch Production at the Bulk Drug Substance facility at Alexion Dublin Manufacturing Facility (ADMF).Provide leadership and direction to the in-house Automation Manufacturing Control System (MCS) team for all automation activities, ensuring system integration and alignment with stakeholder and business goals.Develop and mentor a high-performing team of engineers, fostering a culture of excellence, collaboration, and continuous learning.System Design, Operation, And Maintenance:Direct the design, implementation, and maintenance of the Emerson DeltaV Manufacturing Control System (MCS) ensuring optimal performance and reliability.Lead complex troubleshooting and problem-solving efforts as required, applying technical expertise and experience to ensure minimal disruption to Operations activity.Provide Automation expertise to the Engineering and Operations departments on design and sustaining decisions, to ensure sustainable and supportable design.Work independently to design and implement Automation Change directly as required, with emphasis on supporting review, design-input, and approval as required of Automation Change Packs of in-house Sustaining Automation MCS team.Develop good working relationship and liaise with Front-Line-Support Shift Team - who provide 24/7 support to Emerson DeltaV MCS, and Syncade MES.Regulatory Compliance And Documentation, And Quality Management SystemsEnsure the Manufacturing Control System (MCS) adheres to relevant stringent pharmaceutical regulations and standards (e.g., GxP, FDA 21 CFR Part 11), maintaining full compliance and documentation.Provide Automation ownership and support as required for change records, deviations, and compliance issues, through the Quality Management Systems.Ensure that the Automation MCS design documentation set is maintained.Develop, review, and approve, new and updated standard operating procedures (SOPs) as required.Provide Automation support for Validation activities as required.Provide Automation support for internal and regulatory audits and assessments.Cross-Functional Collaboration And Stakeholder ManagementDevelop good working relationships with stakeholders, and act as the main single-point-of-contact for Sustaining Automation to facilitate stakeholder request prioritisation - ensuring Operations is supported in line with short-term manufacturing goals and long-term design objectives.Communicate and co-ordinate with other MCS user groups (NPI Automation, Technical Services, Process Engineering, Validation etc) on activity requests or code design overlaps as required. Support colleague training and knowledge-sharing as required.Continuous Improvement, Innovation, Sustainability, And Data CommunicationDrive Continuous Improvement initiatives internally in Sustaining Automation MCS team, within wider Automation, and with other departments, for the purposes of sustainability, activity efficiency, process functionality optimization and lean processes.Communicate with and use Data dashboards (PowerBI etc) to share relevant data with stakeholders, to illuminate target opportunities and illustrate issue root cause.Lead efforts to stay at the forefront of emerging trends in automation technology and industry best practice, integrating innovative solutions to enhance operational excellence.Essential QualificationsYou will need to have:Bachelor’s degree in Engineering or Computer Science (e.g., Process, Mechanical, Electrical or Electronic, Controls) or equivalent professional experience.At least 5 years of experience within the process/automation industry supporting GMP environments and applications.At least 4 years of direct experience supporting automation systems in GMP biopharmaceutical production facility (specifically Drug Substance Proteins building or similar processing unit operations).Technical & Role SkillsDirect experience and knowledge of Emerson DeltaV process automation code platform is required.Direct experience of implementing change controls or change records, and supporting deviation or event records, through Quality Management systems, is required.Proven track record as Subject Matter Expert (SME) to guide and lead other technical automation engineers, in support of manufacturing operations.Strong interpersonal skills are required, to collaborate and influence both internal team and external stakeholder management, as well as an ability to communicate effectively both verbally and in written documents.Comprehensive understanding of cGMP requirements for pharmacauetical manufacturing in order to ensure automation systems are cGMP compliant.Understanding of the product quality impact of automation change, and validation and verification approaches.Exceptional leadership and activity management skills, able to prioritise and oversee multiple initiatives effectively in a matrixed environment.We Would Prefer For You To HaveAn advanced degree in Engineering or a related discipline.Direct experience of electronic Automation Change Management systems (e.g.: KNEAT).Understanding of batch process step fundamentals, and ability to consider multi-product impact on automation code design decisions.Familiarity with fundamentals of Manufacturing Control System (MCS) integration with Manufacturing Execution Systems (MES).Experience with OSI PI data, PowerBI, SQL Server is a plus, as is some IT experience.Experience with Hardware instrument layer integration with DeltaV via Profibus and Ethernet to CHARMS.Experience leading and implementing energy efficiency and sustainability efforts in manufacturing environments.Experience of applying LEAN or AGILE methodology.In-depth knowledge of regulatory standards (21 CFR Part 11, EU Annex 11).Direct experience of working with or alongside System Integrators/Vendors.Date Posted26-Jan-2026Closing Date25-Feb-2026Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
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