Brendan Mansfield

As Head of Manufacturing & Maintenance in a rapidly expanding multinational organization, I lead a high-performing team of direct-report managers and over one hundred indirect team members, shaping operational strategy and delivering world-class results. As part of the Senior Leadership Team, my focus is on driving continuous improvement, optimizing resources, and building a culture of excellence across all manufacturing and maintenance operations. I bring a disciplined approach to achieving site KPI metrics—including safety, quality, productivity, and cost—while fostering collaboration across departments to ensure seamless performance. My responsibilities include: • Strategic Workforce Planning: Developing succession roadmaps and building a robust talent pipeline to secure future leadership capability. • Operational Efficiency: Implementing resource optimization strategies and productivity improvements to deliver cost savings without compromising quality. • Leadership & Culture: Inspiring a high-performance team culture that drives engagement and accountability at all levels. • Continuous Improvement: Applying Lean principles and data-driven analysis to resolve complex issues and enhance site performance metrics. • Cross-Functional Collaboration: Building strong partnerships with engineering, quality, and supply chain teams to maximize operational resilience. • Financial Stewardship: Managing budgets for operations, engineering, facilities, and utilities to ensure cost control and strategic investment With proven expertise in manufacturing leadership, maintenance strategy, and performance optimization, I am passionate about delivering sustainable growth and operational excellence in a dynamic, global environment.

As Manufacturing Manager, I led end‑to‑end operations in the Fixatives Value Stream, directing a team of 33 and ensuring consistent achievement of production, safety, quality, and cost objectives in a highly regulated GMP environment. Key Responsibilities & Achievements Directed daily operations, ensuring production targets, compliance, and customer service levels were consistently achieved. Led risk management and risk reduction strategies across the value stream including RA ownership and operational risk registers. Drove EHS & Quality governance: deviation/CAPA management, complaint resolution, audit readiness, and adherence to GMP/quality systems. Acted as Data Integrity Champion, strengthening digital compliance and SAP utilisation across the value stream. Supported NPIs, technical changes, cleaning validation optimisation, and continuous improvement of right‑first‑time performance. Enhanced material accuracy and flow through cycle count management and weekly governance. Owned cost centre activities, including supplier invoicing, PO management, and warehouse cost compliance. Spearheaded CI projects (WPT, RFT uplift, waste reduction) and deployed EBR into the area for the first time.

Operational lead for a major £17m site investment, responsible for ensuring the new line and manufacturing suite were fit for purpose and integrated seamlessly into operations. Developed URS requirements and represented Manufacturing in design reviews. Led FAT/SAT activities and ensured commissioning milestones were met on schedule. Developed operational SOPs, cross-training plans, and change management activities transitioning the area to full commercial readiness. Collaborated with Technical and Cleaning Validation to optimise CIP and introduce new processes.

Delivered EHS, Quality, and CI governance across the site, ensuring operational standards, audit readiness, and regulatory compliance. Directed risk assessments, audits, investigations, and reporting to EHS Councils. Managed deviations, CAPAs, customer complaints, vendor issues, and quality metrics. Implemented GPS/Lean standards including Gemba, problem solving, visual management, and zoning.

EHS Management: Risk assessments, , Near Miss/ZAP Database, investigating and closing out ZAPs, Incident reporting, Gemba with Purpose. Quality Management: Hosting Area Quality Monthly Meetings - managing Deviations and CAPA, investigating and closure of Customer Complaints, monthly level 1 schedule, completing level 1 audits, attending Level 2 audits, Level 2, 3 and 4 audit findings closure, audit readiness preparations, CDMS- documentation updating and approval, Quality Near Miss process management, Service Supplier's review, Managing Vendor Complaints Continuous Improvement: Visual Management, Problem solving, GEMBA, 6's and zoning. Provide support in the manufacturing and packaging processes. Provide motivational and effective supervisory direction for department team members. Develop own levels of knowledge and FLL Leadership skills. Ensuring that all-manufacturing / packaging equipment is operating correctly to achieve optimum efficiency. Ensure that highest quality and safety standards are maintained at all times within the area. Lead/Coach manufacturing / packaging personnel and help build a good working Team Environment. Optimize raw material / component usage. Responsible for informing the Maintenance/Automation, IT and Technical depts. of any issues that may be impacting production in the area. Contribute to programs of continuous improvement in relation to all aspects of the manufacturing & packaging processes within the area. Conduct formal / informal EHS audits / checks on a daily / weekly basis. Generate Accident Reports & participate in Accident / Incident investigation. Manage the area during any unforeseen situations.

Responsible for maintaining the Process area, ensuring that specified outputs and targets are achieved. Ensuring that all Manufacturing equipment is operating correctly to achieve. optimum efficiency. Maintain a close working relationship with immediate Supervisor in order to ensure that all issues either Manufacturing or Operator related are reported and dealt with in a correct and timely manner. Ensure that highest Quality and EHS standards are always maintained within the area. Ensure all housekeeping standards are fully maintained. Lead and coach Manufacturing personnel and help build a good working team environment. Optimize manufacturing equipment to achieve and exceed production as per specified output standards. Ensure that all equipment clean downs within the Manufacturing area are carried out as per designated SOP’s, monitoring and driving same ensuring they are achieving specified targets. Be responsible for informing the Maintenance department of any issues that may be impacting production within the area. Ensure that incoming SPO is informed of all manufacturing efficiencies or deficiencies. Liaise with Supervisor re. current or upcoming orders to minimise the requirement to drum off excess bulk. Ensure that people are at their place of work and all equipment is sufficiently manned, liaising with Supervisor re. manning levels and Operator availability

As per below

Cross Trained as part of site restructure to be a Bulk Manufacturing Operative across the two Value Streams on site. Trained and capable to manufacture on multiple different equipment to produce multiple different formulations. Use / storage / maintenance / cleaning of all equipment within the relevant areas in the manufacturing operations dept. as per approved documentation including SOP’s / Batch Documents / PO’s / etc. Achievement of operational targets including but not limited to OEE / RFT / Doc Error / c/o/ Waste reduction targets. Involvement with work centre-based Teams / Teamwork initiatives including but not limited to design / development / and implementation of Teamwork based projects e.g. audits, inspections, project implementation. Involvement and active participation with Continuous improvement projects and GPS Training / instruction of fellow Operatives as designated by relevant supervisor Accurate reporting of department measures / metrics / controls which may be assigned. Maintaining and control of specialised equipment and tools in relevant areas. Completion of all Manufacturing and Packaging in process testing as per approved Documentation / SOP's / Batch Documents / Policies Ensure Halal requirements are met in accordance with General Guidelines of Halal Assurance System LPPOM MUI for applicable Medical Device products / markets. Compliance with Safety standards / Polices / procedures when conducting or carrying out normal duties or work practices. Report all near misses, accidents, or dangerous occurrences to their department Manager/Supervisor immediately or as soon as is practicable thereafter. Document all near miss/ accidents in conjunction with team Leader/Supervisor Cast the right shadow and lead by example. Compliance with quality standards / procedures / policies / SOP’s and all other approved documentation.

Cross trained and worked across both Value Streams in Manufacturing Operations Achievement of operational targets including but not limited to OEE / RFT / Doc Error / c/o/ Waste reduction targets. Training / instruction of fellow Operatives as designated by relevant supervisor. Completion of all Manufacturing and Packaging in process testing as per approved Documentation / SOP's / Batch Documents / Policies Ensure Halal requirements are met in accordance with General Guidelines of Halal Assurance System LPPOM MUI for applicable Medical Device products / markets

University of Limerick accredited Blackbelt