Job Summary

• Lead and execute technical Life Cycle Management (LCM) projects for existing finished goods in collaboration with external manufacturing partners ensuring projects are completed on schedule, within scope, and in accordance with business objectives.
• Provide technical oversight and project leadership for external manufacturing partners.  Assess and develop project scope, business case and technical feasibility and ensure effective implementation in alignment with business, quality, and regulatory requirements.
• Utilize business and quality systems, including PLM (Windchill), to manage documentation, change controls, and project-related activities.
• Partner/lead with various cross functions such as Quality, Research & Development, Regulatory Affairs, Source, Plan, and Operations to execute supply chain priorities, change requests and deliver projects successfully.
• Facilitate collaboration between internal stakeholders and external partners, proactively resolve issues, mitigate technical and operations risks, and maintain customer service commitments.
• Review and approve technical documentation, including engineering drawings, manufacturing process documentation, IQ/OQ/PQ protocols, qualification reports, and validation activities for new and existing processes, equipment, and systems.
• Manage Asset Decommissioning disposal requests with external manufacturing partner and coordinate disposition activities needed with internal business partners.

Key Responsibilities

• Lead and execute technical Life Cycle Management (LCM) projects for existing finished goods in collaboration with external manufacturing partners ensuring projects are completed on schedule, within scope, and in accordance with business objectives.
• Provide technical oversight and project leadership for external manufacturing partners.  Assess and develop project scope, business case and technical feasibility and ensure effective implementation in alignment with business, quality, and regulatory requirements.
• Utilize business and quality systems, including PLM (Windchill), to manage documentation, change controls, and project-related activities.
• Partner/lead with various cross functions such as Quality, Research & Development, Regulatory Affairs, Source, Plan, and Operations to execute supply chain priorities, change requests and deliver projects successfully.
• Facilitate collaboration between internal stakeholders and external partners, proactively resolve issues, mitigate technical and operations risks, and maintain customer service commitments.
• Review and approve technical documentation, including engineering drawings, manufacturing process documentation, IQ/OQ/PQ protocols, qualification reports, and validation activities for new and existing processes, equipment, and systems.
• Manage Asset Decommissioning disposal requests with external manufacturing partner and coordinate disposition activities needed with internal business partners.

Skill Requirements

Other Requirements