• Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.

• Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.

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.

Key Duties and 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.

Education, Experience, and Qualifications

• Bachelor's Degree Bachelors of Science (or advanced degree) in the field of Chemistry/Chemical Engineering, Microbiology, Life Sciences, Biomechanical Engineering. required
• 5+ Years Minimum of 5 years reagent Operations experience in a relevant ISO 13485 and/or FDA regulated setting preferred
• 2+ Years 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
• 1+ Year 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

Physical Demands and Working Conditions

• Writing - Frequently
• Typing - Frequently
• Bending - Occasionally
• Color vision on the job - Constantly
• Lifting 20-50 lbs - Frequently
• Must work onsite at Luminex office - Constantly
• Work is typically performed in an office environment. - Frequently
• Possible exposure to mechanical, biological, and chemical hazards. - Frequently
• Possible exposure to Chemicals, Lasers, Excessive Noise, etc. - Frequently
• Work in manufacturing setting which may include BioSafety Level 2 areas; work may be performed in fume hood, clean hood, biosafety cabinet, and/or ISO Class 7 cleanroom with specialized gowning and safety requirements - Frequently
• Work in walk-in refrigerators and freezers that encompass conditions down to -20C - Frequently
• Work situations include dealing with people; working alone; making judgments and decisions; and directing, controlling or planning the activity of others - Frequently
• Frequent use of personal computer and office equipment. - Frequently
• Frequent use of data and word processing programs. - Frequently
• 10% Travel may be required at least 10% of the time

Whatweoffer

Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.