Manufacturing Engineer - Scientist I

diasorinsp•Austin, TX

2d•Onsite

About The Position

Obsessed by Science. Entrepreneurial by Nature. United by Purpose. Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions. As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry’s broadest specialty diagnostic portfolios. When you join Diasorin, you are not just filling a role. You are helping build what comes next. Why Join Diasorin Build What MattersTake ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide. Innovate with Agility at a Global ScaleWork in an entrepreneurial environment that enables speed, collaboration, and global impact. Grow in a People-Centered CultureThrive in a culture that values accountability, inclusion, and continuous development. Job Scope The Manufacturing, Scientist 1 will be responsible for: Representing Operations in design teams for new and on market product design and development, design transfer, and market phases. Facilitating in defining project tasks, establishing timelines, and fulfilling responsibilities for product design transfer and related process engineering. Collaborating on the development and assuming full ownership at Production release of material specifications, manufacturing processes, test methods, analysis tools, work instructions, stability studies, and related acceptance criteria for new or on market product. Leading and assisting in sustaining engineering projects for improvement of manufacturing process, cleaning processes, stability methods, test methods, product specifications, process/test equipment/fixtures, analysis tools, and business systems. Identifying opportunities for process innovations. Developing product stability plans, protocols, and reports for the Stability Program. Facilitating the investigation and resolution of findings identified through audits, non-conformances, corrective/preventative actions, or customer complaints. Task-specific and change control training of manufacturing personnel. Supporting a Manufacturing/QC operation which may be a high complexity, high product mix, small/large run production environment with batch processing up to ~4000 Liters; including standard and custom product lines encompassing critical organic synthesis intermediates, general purpose reagents, IVD system reagents, Public Health, Food Safety, and cellular analysis assay products.

Requirements

Bachelor's Degree Bachelors of Science (or advanced degree) in the field of Chemistry/Chemical Engineering, Microbiology, Life Sciences, Biomechanical Engineering. required
Minimum of 5 years reagent Operations experience in a relevant ISO 13485 and/or FDA regulated setting preferred
Minimum of 2 years’ experience servicing reagent Operations with process improvement, and/or sustaining engineering, and/or design transfer in a Life Sciences, Chemistry, Biomechanical Engineering, or Medical Technology field. preferred
Experience working independently or as a team member in a fast-paced environment with rapidly changing priorities preferred
Thorough knowledge of ISO 13485 and FDA Quality System requirements
Knowledge of Enterprise Resource Planning, including applied knowledge of engineering functionality
Proficiency in the use of Product Lifecycle Management, including applied knowledge of Engineering Change Control
Applied knowledge of Process and Test Method Validations as required by FDA Quality System guidelines
Knowledge of Design Control requirements as defined by the FDA Quality System guidelines
Proven results through application of Six Sigma and Lean Manufacturing principles, including applied knowledge of statistical design of experiments
Mathematics and statistics aptitude.
Data analysis and technical writing aptitude.
Excellent oral and written communication skills.
Proficient in Microsoft Word, Excel, and PowerPoint programs.
Highly organized with proven time management and prioritization skills
Ability to work independently and with minimal supervision
Ability to handle the pressure of meeting tight deadlines

Responsibilities

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 for improvement of manufacturing processes, cleaning processes, stability methods, test methods, product specifications, process/test equipment/fixtures, analysis tools, and Enterprise Resource Planning.
Identify opportunities for process innovations and improvement.
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, work instructions and related acceptance criteria for new or on market product.
Assist in design input and implementation oversight of infrastructure improvement projects.
Establish and maintain standard architecture of BOMs and routings related to new or existing Operation processes in Enterprise Resource Planning
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; collaborate with R&D as required.
Assume full ownership of equipment and test fixture validation planning, execution, and reporting; collaborate with R&D as required.
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.
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.
Participate in design and implementation of new quality initiatives 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 regulations.
Ensure personal safety compliance and influence sectional safety compliance.
Ensure compliance to NFPA, OSHA, lock-out, and other applicable safety standards.
Other duties as assigned.