Manufacturing Scientist

Manufacturing Scientist – Diasorin

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Diasorin is a global leader in diagnostic solutions with over 50 years of experience creating cutting‑edge tools that improve health care worldwide. Our diverse portfolio of diagnostic tests and licensed technology solutions positions us as a specialist in the sector, backed by continuous investment in research and innovation.

• Impactful work that directly improves patient care.
• Global reach and collaboration with colleagues worldwide.
• Inclusive culture that values diverse perspectives.

The Manufacturing Engineering Scientist represents Operations in design teams for new and on‑market product design and development, design transfer, and market release phases. Responsibilities include leading sustaining engineering projects, identifying process innovations, managing the Stability Program, and overseeing change control training for manufacturing personnel. The role supports a high‑complexity, high‑product‑mix environment with batch processing up to 2000 L.

• Represent Operations in design teams; fulfill design transfer responsibilities for new and on‑market product development, validation, and market release phases.
• Lead and assist in sustaining engineering projects to improve manufacturing processes, cleaning processes, stability methods, test methods, and product specifications.
• Lead and assist in design input and implementation oversight of infrastructure improvement projects.
• Identify and drive opportunities for process innovations, improvements, and cost reductions.
• Participate and drive development and implementation of process automation strategies and solutions.
• Assume full ownership of sustaining support for on‑market processes.
• Participate in product feasibility collaborations with R&D, as needed.
• Lead and assist in engineering change control and document change control activities; participate in change control reviews.
• Collaborate with R&D on the development of material specifications, manufacturing processes, test methods, analysis tools, work instructions, and related acceptance criteria for new or on‑market product prototype release.
• Assume full design transfer ownership for Production and Market release of material specifications, manufacturing processes, test methods, analysis tools, and work instructions for new or on‑market product.
• Establish and maintain standard architecture of BOMs and routings related to Reagent Operation processes in ERP.
• Interface with Cost Accounting for new or existing product COGs roll‑up.
• Perform cost/benefit analysis for product/process improvement projects.
• Collaborate with R&D on OQ process validation planning and execution.
• Assume full ownership of PQ process validation planning, execution, and reporting; collaborate with R&D as required.
• Assume full ownership of test method and analysis tool validation planning, execution, and reporting.
• Assume full ownership of equipment and test fixture validation planning, execution, and reporting.
• Ensure effective training of Manufacturing and Quality Control personnel for transfer of new processes.
• Responsible for knowledge transfer of new product designs being transferred into Operations.
• Develop product stability plans, protocols, and reports.
• Provide training and oversight for stability study execution.
• Drive the administration of the Reagent Stability Program and identify gaps.
• Lead and assist the investigation and resolution of findings impacting the organization identified through audits, non‑conformances, corrective/preventative actions, or customer complaint escalation.
• Identify processes requiring statistical process control and implement control charts via Control Charting Program.
• Assist in establishing annual goals and objectives; fulfill individual goals and objectives.
• Lead or participate in the development and implementation of new departmental initiatives, policies, and programs.
• Participate in or conduct applicable departmental, interdepartmental and intra‑departmental training.
• Ensure personal compliance and influence sectional compliance with the Quality System and other…