TSP

Stevanato Group S.p.A. • Fishers, IN

9d

About The Position

Responsible for coordinating assigned projects related to the introduction of new products, processes, and technological solutions into production to maximize process efficiency and lifecycle management. This role leads technology transfer, ensuring a smooth transition from trial and testing to full production while maintaining process validation status. The position operates in alignment with the Quality Management System (QMS), safety, regulatory requirements, and customer expectations, collaborating with functions such as R&D, Quality, Engineering, and Operations Teams.

Requirements

• Coordination of project teams for new product/process introduction.
• Conducting feasibility studies.
• Proposing, designing, and introducing technological solutions.
• Leading risk assessments and troubleshooting technical issues.
• Managing deviations and change control.
• Elaborating technical transfer documents, quality attributes, and critical parameters.
• Ensuring timely and efficient process implementation.
• Setting up plans and achieving milestones and targets.
• Contributing to lifecycle management projects.
• Ensuring compliance with quality standards and regulatory requirements.
• Enabling user requirement collection for equipment concepts.
• Coordinating and monitoring introduction of new technologies, infrastructure changes, and information systems.
• Managing testing processes (FAT, SAT) and qualification processes.
• Enhancing existing operations.
• Participating in cross-functional teams for validation plans.
• Maintaining process validation status.
• Ensuring documentation for process and equipment changes.
• Providing process performance analysis and proposing corrective actions.
• Monitoring KPI dashboards and highlighting critical issues.
• Coordinating compilation of reports and documents.
• Managing recovery plans for project timelines.
• Cascading procedures and guidelines to project teams.
• Driving operative implementation across functions.
• Maintaining understanding of regulatory requirements for validation.
• Leading assigned area projects.
• Presenting analysis and reports to leadership for decision-making.
• Dealing with external stakeholders.
• Collecting and transmitting market standards and trends.
• Interacting with internal functions and suppliers for material and technology sourcing.

Responsibilities

• Coordinate assigned project teams for the introduction of new products/processes and technological solutions to ensure successful production launch.
• Conduct feasibility studies to ensure consistency and maximize process efficiency.
• Propose, design, and introduce improved technological solutions to maximize process efficiency.
• Lead risk assessments, report potential critical issues, and troubleshoot technical product issues, deviations, and change controls.
• Elaborate technical transfer documents, including quality attributes, critical quality attributes, process capabilities gaps, and critical parameters.
• Provide input during the early development phase to ensure timely and efficient process implementation at manufacturing scale and vice versa.
• Set up plans and achieve agreed milestones and targets, providing inputs to involved functions for a feasible transition to production and cost minimization.
• Contribute to lifecycle management projects, ensuring compliance with quality standards and regulatory requirements.
• Enable user requirement collection during new/revised equipment concepts, ensuring necessary documents and reports for investment proposals.
• Coordinate and monitor projects related to the introduction of new technologies, infrastructure changes, expansions, processes, and information systems.
• Manage relevant testing processes (e.g., FAT, SAT) and qualification processes with external and internal stakeholders.
• Enhance existing operations to strive for excellence.
• Participate in cross-functional teams to establish validation plans and objectives for process and equipment changes.
• Maintain process validation status and ensure all relevant documentation (operating procedures, protocols, specifications) is in place.
• Provide robust and accurate process performance analysis on yield variances, identify causes, and propose corrective and preventive actions.
• Monitor the operation KPI's dashboard, highlight critical issues, and propose solutions to leadership.
• Ensure efficient and effective operative execution within the relevant area.
• Coordinate the timely compilation of relevant reports and documents (e.g., deviations, change requests).
• Monitor project progression in terms of timing, performances, and outcomes delivery.
• Manage recovery plan execution to ensure expected results within agreed timescales.
• Cascade relevant procedures, guidelines, and documents to assigned project teams.
• Drive operative implementation across involved functions.
• Maintain an ongoing understanding of the latest regulatory requirements for validation to ensure compliance.
• Lead assigned area projects, coordinating project teams in alignment with planned priorities and activities.
• Ensure timely and consistent achievement of project targets.
• Present in-depth analysis and reports to leadership to facilitate decision-making on critical points by evaluating project scenarios and their impacts.
• Deal with external stakeholders (industrial players, customers, technical providers) to promote business expertise and competitive advantage.
• Collect standards and trends from external stakeholders and transmit them to relevant functions to ensure compliance and drive future development.
• Interact with internal functions or suppliers to provide input for sourcing necessary materials and technologies.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed