Manufacturing Lead

3 days ago

Loughrea, Galway, Ireland Chanelle Pharma Full time
Overview

Chanelle Pharma is seeking a highly experienced and strategic Manufacturing Lead to join our ambitious ERP transformation programme. This role will lead the design, implementation, and optimisation of manufacturing processes as part of our SAP S/4HANA Cloud ERP rollout. Operating within a regulated pharmaceutical environment, the Manufacturing Lead will play a critical role in aligning operations with best practices, compliance standards, and business objectives.

Location: Onsite 5 Days Per Week in our Loughrea Facility.

Key Responsibilities
  • Manufacturing Strategy & Execution
  • Lead the development and execution of manufacturing strategies aligned with business and regulatory requirements
  • Define and implement best practices for process manufacturing, including work order execution, multi-level BOMs, sub-assemblies, and recipes
  • Serve as the Manufacturing Workstream Lead within the SAP S/4HANA Cloud ERP programme, following an "Adopt not Adapt" methodology
  • Collaborate with SAP consultants, ERP project team, production planners, quality, and IT to configure manufacturing parameters, routings, and integration points
  • Ensure accurate and compliant setup of manufacturing master data (materials, BOMs, routings, production versions)
  • Create and maintain process documentation and participate in ERP testing phases to validate manufacturing functionality
GxP Compliance & Validation
  • Ensure manufacturing processes comply with GxP regulations, including 21 CFR Part 11 and EU GMP Annex 11
  • Support Computer System Validation (CSV) activities and implement controls for electronic signatures, audit trails, and batch traceability
Stakeholder Engagement
  • Act as the primary liaison for all production-related ERP matters across internal departments
  • Facilitate workshops and training sessions to promote process ownership and operational excellence
Operational Excellence
  • Define and monitor manufacturing KPIs (e.g., throughput, yield, downtime) post-ERP implementation
  • Drive improvements in production scheduling, resource utilization, and shop floor visibility
Skills & Competencies
  • Proven leadership in manufacturing workstreams within large-scale ERP implementations
  • Deep expertise in SAP S/4HANA or SAP Cloud ERP, especially in regulated pharmaceutical or CDMO environments
  • Hands-on experience with:
    • Production Planning (PP) and Manufacturing Execution (ME)
    • Multi-level BOMs, routings, recipes
    • Batch management and traceability
  • Familiarity with SAP Best Practices and Fit-to-Standard methodologies
  • Strong understanding of GxP, CSV, and ALCOA++ principles
  • Excellent communication, leadership, and stakeholder management skills
  • Experience with process mapping tools and data governance
Experience & Qualifications
  • Senior leadership experience in manufacturing or operations within regulated pharma or CDMO environments
  • Demonstrated success in ERP implementation, particularly SAP
  • Relevant academic qualifications in engineering, manufacturing, or life sciences
  • SAP certification or supply chain/manufacturing credentials (desirable)
  • Experience with AI/ML tools for production optimisation and predictive maintenance (desirable)

Applicants from diverse backgrounds, including those returning after a career break or with transferable skills from non-traditional career paths, are encouraged to apply. We value varied experiences and are committed to fostering an inclusive environment that supports individuals with disabilities.


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