MCS Lead Automation Engineer – BDS MCS

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:

Leadership andOversight:

• 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.

System Design, Operation, and Maintenance:

• 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.  

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.

• 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.

Cross-Functional Collaboration andStakeholderManagement:

• 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.

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.

• 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 & Role Skills:

• Direct experience and knowledge of EmersonDeltaVprocess automation code platform is required.

• Direct experience of implementing change controls or change records, and supporting deviation or event records, through Quality Management systems,isrequired. 

• Proven track record as Subject Matter Expert (SME) to guide and lead other technical automation engineers, in support of manufacturing operations.

• 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.

• Comprehensive understanding of cGMP requirementsforpharmacaueticalmanufacturingin order toensure automation systems are cGMP compliant. 

• Understanding of the product quality impact of automation change,and validation and verification approaches.

• Exceptional leadership andactivitymanagement skills, able toprioritiseand oversee multiple initiatives effectivelyin a matrixed environment.

We wouldpreferforyou to have:

• An advanced degree in Engineering or a related discipline.

• Direct experience ofelectronicAutomation Change Management systems (e.g.:KNEAT).

• Understanding ofbatchprocess step fundamentals, and ability to consider multi-product impact on automation code design decisions.

• Familiaritywithfundamentals of Manufacturing Control System (MCS) integration with Manufacturing Execution Systems (MES).

• Experience with OSI PI data,PowerBI, SQL Serveris a plus, as is some IT experience.

• Experience with Hardwareinstrument layer integration withDeltaVvia Profibusand Ethernet toCHARMS.

• Experience leadingand implementingenergy efficiency and sustainability efforts in manufacturing environments.

• Experience ofapplying LEAN or AGILEmethodology. 

• In-depth knowledge ofregulatory standards (21 CFR Part 11, EU Annex 11).

• Direct experience of working with or alongside System Integrators/Vendors.