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About the Role

The Manufacturing, Scientist 1 will represent Operations in design teams for new and on-market product design and development, design transfer, and market phases. This role facilitates defining project tasks, establishing timelines, and fulfilling responsibilities for product design transfer and related process engineering. The position collaborates on the development and assumes 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. The role also leads and assists 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, while identifying opportunities for process innovations and developing product stability plans, protocols, and reports.

Responsibilities

Represent Operations in design teams for new and on market product design and development, design transfer, and market phases.
Facilitate in defining project tasks, establishing timelines, and fulfilling responsibilities for product design transfer and related process engineering.
Collaborate on the development and assume 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.
Lead and assist 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.
Identify opportunities for process innovations.
Develop product stability plans, protocols, and reports for the Stability Program.
Facilitate the investigation and resolution of findings identified through audits, non-conformances, corrective/preventative actions, or customer complaints.
Provide task-specific and change control training of manufacturing personnel.
Support 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.
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.

Requirements

Bachelor's Degree in Chemistry/Chemical Engineering, Microbiology, Life Sciences, or Biomechanical Engineering.
Minimum of 5 years reagent Operations experience in a relevant ISO 13485 and/or FDA regulated setting.
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.
Experience working independently or as a team member in a fast-paced environment with rapidly changing priorities.
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.
Must work onsite at Luminex office.
Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law.
Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process.

Skills

Process improvement
Sustaining engineering
Design transfer
Six Sigma
Lean Manufacturing
Statistical design of experiments
Data analysis
Technical writing
Microsoft Word
Microsoft Excel
Microsoft PowerPoint
Time management
Prioritization

Location

Onsite at Luminex office

Work Type

Onsite
Full-time

Experience Level

5+ Years
2+ Years
1+ Year

Education Level

Bachelor's Degree in Chemistry/Chemical Engineering, Microbiology, Life Sciences, or Biomechanical Engineering.
Advanced degree in Chemistry/Chemical Engineering, Microbiology, Life Sciences, or Biomechanical Engineering.

Benefits

Competitive salary and benefits package

About the Company

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide.
For more than 50 years, Diasorin has combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.
Diasorin continuously invests in research, technology, and people.
Guided by values of operational excellence, customer focus, and teamwork, Diasorin empowers teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry’s broadest specialty diagnostic portfolios.
Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers.
Diasorin believes diverse perspectives strengthen innovation and help deliver meaningful impact for patients and customers worldwide.

Equal Opportunity

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.
This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction.