This is what you will do:
As the‘MCSLead Automation Engineer–BDS MCS’, you will overseethekeybatchprocessManufacturingControlSystem at College Park. Your role will includeownership of:
Manufacturing Control System(MCS):This is theEmersonDeltaVcontrol systemintegratingwithprocessequipmentfromUpstream Bioreactors and Media, through Harvest Centrifuge and Filtration, to Downstream Buffer, Chromatography, Ultrafiltration, Viral Inactivation and Viral Filtration through to Final Fill.
We seek a seasoned Lead Engineer to handle and optimise thissystem within our advanced pharmaceutical facility, ensuring adherence to regulatory standards and operational excellence. Experience withDeltaVbatchlayerand continuouslayercontrol is essential, witha strong background inGxP-regulated environments.
You willbe responsible for:
Develop and mentor a high-performing team of engineers, fostering a culture of excellence, collaboration, and continuous learning.
System Design, Operation, and Maintenance:
Work independently todesign andimplement Automation Change directly asrequired, with emphasis on supporting review, design-input, and approvalas requiredof Automation Change Packs of in-house Sustaining Automation MCS team.
Regulatory Compliance and Documentation, and Quality Management Systems:
Ensurethe Manufacturing Control System (MCS)adherestorelevantstringent pharmaceutical regulations and standards (e.g.,GxP, FDA 21 CFR Part 11),maintainingfull compliance and documentation.
Provide Automation ownership and support asrequiredfor change records,deviations,and compliance issues, through the Quality Management Systems.
Cross-Functional Collaboration andStakeholderManagement:
Communicate and co-ordinate with other MCS user groups (NPI Automation, Technical Services, Process Engineering, Validation etc) on activity requests or codedesign overlaps asrequired.Support colleague training and knowledge-sharing asrequired.
Continuous Improvement, Innovation,Sustainability, and Data Communication:
DriveContinuous Improvementinitiativesinternally in Sustaining Automation MCS team, within wider Automation, and with other departments, for the purposes of sustainability, activity efficiency,process functionalityoptimizationand lean processes.
Essential Qualifications:
Bachelor’s degree in Engineeringor Computer Science(e.g., Process,Mechanical, Electricalor Electronic, Controls) or equivalent professional experience.
Direct experience of implementing change controls or change records, and supporting deviation or event records, through Quality Management systems,isrequired.
Strong interpersonal skills arerequired,to collaborate and influence bothinternal team and external stakeholder management,as well as an ability to communicateeffectivelyboth verbally and in written documents.
We wouldpreferforyou to have:
Date Posted
26-Jan-2026
Closing Date
25-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.