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.
Sustaining Automation MCS Support :Leadership and oversight to our in-house AutomationManufacturing Control System(MCS)team.
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: Providemainsingle-point-of-contactfor stakeholdersfor Sustaining Automation (MCS) support forGxPBatch Production the Bulk Drug Substance facility at Alexion Dublin Manufacturing Facility (ADMF).
Provideleadership and directionto the in-house Automation Manufacturing Control System (MCS) teamfor all automation activities, ensuring system integration and alignment withstakeholder andbusiness goals.
Develop and mentor a high-performing team of engineers, fostering a culture of excellence, collaboration, and continuous learning.
Direct the design, implementation, and maintenance of the EmersonDeltaVManufacturing Control System (MCS)ensuringoptimalperformance and reliability.
Lead complex troubleshooting and problem-solving effortsasrequired, applying technicalexpertiseand experienceto ensure minimal disruption toOperationsactivity.
ProvideAutomationexpertiseto the Engineering and Operations departments on design and sustaining decisions, to ensure sustainable and supportable design.
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.
Developgood workingrelationship and liaise with Front-Line-Support Shift Team-who provide 24/7 support to EmersonDeltaVMCS, andSyncadeMES.
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.
Ensure that the Automation MCS design documentation set ismaintained.
Develop, review, and approve, new and updated standard operating procedures (SOPs) asrequired.
Provide Automation support for Validation activities asrequired.
Provide Automation support for internal and regulatory audits and assessments.
Develop good working relationships withstakeholders, and act asthe main single-point-of-contact for Sustaining Automation tofacilitatestakeholder request prioritisation-ensuringOperations is supported in line with short-termmanufacturinggoals and long-termdesignobjectives.
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.
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.
Communicate with and use Data dashboards (PowerBIetc)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 technologyand industry best practice,integrating innovative solutions to enhance operational excellence.
You will need to have: Essential Qualifications: Bachelor's degree in Engineeringor Computer Science(e.g., Process,Mechanical, Electricalor Electronic, Controls) or equivalent professional experience.
At least5years of experiencewithin the process/automation industry supporting GMP environments and applications.
At least 4 years ofdirectexperience supporting automation systems in GMP biopharmaceutical productionfacility(specifically Drug Substance Proteins building or similar processing unit operations).
Technical