Manufacturing Engineer Scientist II

Diasorin is a global leader in diagnostic solutions pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years weve earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.

Our broad offering of diagnostic tests and Licensed Technology solutions made available thanks to ongoing investments in research positions us as the player with the widest range of specialty solutions in the sector and identifies us as the Diagnostics Specialist.

Why Join Diasorin

• Impactful Work: When you join Diasorin you become part of a team thats 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.

Diverse and Inclusive Culture: We believe in the strength of diversity and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive collaborative environment where everyone can thrive.

Join Our Team: If youre passionate about innovation diversity and making a positive impact on healthcare Diasorin is the place for you. Were looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.

Are you ready to be part of a dynamic team thats shaping the future of diagnostics Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier more connected world. Together we can make an impact!

Job Scope

The Manufacturing Engineering Scientist II 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.

This position will be 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 such as automation implementation developing product stability plans protocols and reports and managing the Stability Program leading or assisting with the investigation and resolution of findings identified through audits non-conformances corrective/preventative actions or customer addition this position will manage task-specific and change control training of manufacturing personnel. and play role in supporting a Manufacturing/QC operation which may be a high complexity high product mix small/large run production environment with batch processing up to 2000 Liters. May include standard and custom product lines spanning molecular and immunodiagnostic assays critical organic synthesis intermediates general purpose reagents IVD system reagents public health food safety and cellular analysis assay products.

Job Duties and Responsibilities

• Represent Operation 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.
• Lead and assist in design input and implementation oversight of infrastructure improvement projects.
• Identify and drive opportunities for process innovations improvement 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 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 Reagent 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 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; 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 regulations.
• Ensure personal safety compliance and influence sectional safety compliance
• Lead and assist external design transfers and contract manufacturing scenarios.
• Provide packaging and labeling design support to R&D.
• Identify processes for potential improvement and drive/lead Lean Six Sigma project to resolve the issue or inefficiency
• Ensure compliance to NFPA OSHA lock-out and other applicable safety standards.
• Ensure adherence hazardous waste disposal and gowning requirements.
• Other duties as assigned.

Education Experience and Qualifications

• Bachelors Degree Bachelors of Science (or advanced degree) in the field of Chemistry/Chemical Engineering Microbiology Life Sciences Biomechanical Engineering required
• 8 Years reagent Operations experience in a relevant ISO 13485:2003 and/or FDA regulated setting. Required
• 5 Years experience servicing reagent Operations with process improvement and/or sustaining engineering and/or design transfer in a Life Sciences Chemistry Biomechanical or
• Medical Technology field. Required
• 1 Years Experience working independently or as a team member in a fast-paced environment with rapidly changing priorities required
• Thorough knowledge of ISO 13485 and FDA Quality System requirements
• Certified Quality Engineer (CQE) preferred but not required
• Proficiency in Enterprise Resource Planning including applied knowledge of engineering functionality and familiarity with Manufacturing Execution Systems
• 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 expertise in automation solutions for high complexity high product mix small/large run production environment with batch processing up to 2000 Liters
• Proven expertise in design and implementation of infrastructure improvements
• 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

Standard Working Conditions

• Must work onsite at Luminex office
  Work is typically performed in an office environment
  Possible exposure to mechanical biological and chemical hazardsy
  Possible exposure to Chemicals Lasers Excessive Noise etc. -
  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
  Work in walk-in refrigerators and freezers that encompass conditions down to -20C -
  Work situations include dealing with people; working alone; making judgments and decisions; and directing controlling or planning the activity of others
  Frequent use of personal computer and office equipment.
  Frequent use of data and word processing programs.

Travel Requirements

• 10% Travel may be required
  

What we offer

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.

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 or protected veteran status and will not be discriminated against on the basis of disability.

In compliance with federal law all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.

Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process please contact the North America Talent Acquisition Team at or 1- to request an accommodation.

The above job description is intended to describe the general content identify the essential functions and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties responsibilities or requirements.

Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.

Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen subject to applicable laws and regulations.

This position is not eligible for partnership with a third-party search firm vendor without expressed written consent from the Diasorin Human Resources Department.