Kind of contract
For over 40 years, DiaSorin has been on a mission on five continents to develop, produce and commercialize diagnostic tests for a wide range of clinical areas. Our tests are designed for hospitals and private testing laboratories, in the markets of immunodiagnostics and molecular diagnostics.
DiaSorin Molecular, LLC is headquartered in Cypress, Ca. Our technology enables diagnosis of disease by detecting specific RNA and DNA sequences. We focus on design, development and cGMP Manufacturing.
We believe in a respectful and supportive workplace that attracts and celebrates the uniqueness of a diverse workforce that represents our community and customers.
What you will do:
The Manufacturing Engineering team is responsible for the innovation of new production systems as well as the industrialization and sustainment of such systems. Sr. Engineer is responsible to apply engineering principles to create practical solutions to technical challenges and provide technical support across functions with minimal supervision. Apply skills in the areas of equipment designs, process scale-up from R&D, process improvement of existing processes and implementation of automated control systems.
Also plan, coordinate and drive all necessary activities to validate manufacturing facilities, equipment and processes. evaluate and optimize processes to improve product consistency and to increase productivity. Support company goals and objectives, policies and procedures and FDA regulations. Assist in the development and performance of validations on equipment. Support applicable regulations including ISO13485, Local, State, and/or Federal requirements.
Qualifications Experience Personal Strengths Mobility
What you bring to the table:
• Bachelor’s degree in an engineering discipline such as Bio-Medical, Mechanical, Material or Industrial Engineering
• 5 plus years related experience in IVD, medical, pharmaceutical, or other related industry
• Extensive experience in equipment and process validation in Medical device or pharmaceutical
• Process automation experience strongly preferred
• Thorough understanding of statistical quality control, statistical process control, corrective action process, and their application manufacturing as a problem identification and resolution tool
• Proficient in Advanced SPC, Quality Analysis Tools (Taguchi, Fishbone), FMEAs & DOE
• Demonstrated experience in application of LEAN manufacturing principles.
• Strong computer skills in Microsoft Office applications, Solidworks and Minitab. Familiarity with
Google Suite is a plus.
• Ability to write reports, business correspondence, and effectively present information
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
• The employee must occasionally lift and/or move up to 25 pounds. Specific vision requirements
involve close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.
• Plan and execute the implementation, and successful scale-up of automated and semi-automated solutions based upon sound engineering principles
• Lead improvement initiatives to improve production processes to increase productivity,
manufacturing yields, reduce production costs and decrease or eliminate scrap.
• Initiate protocol, execute and write final report for validation of equipment and processes
• Design and develop new manufacturing processes, sequence of operations, procedures and
production layouts for assemblies, equipment installation, processing and material handling based on product design requirements.
• Design tooling and fixtures as needed in order to enhance productivity and product quality.
• Writes clear and detailed manufacturing SOPs, URS, Engineering reports, ECRs, and other technical documents.
• Perform capacity, equipment efficiency, and labor utilization analysis to optimize manufacturing processes.
• Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
• Troubleshoot manufacturing process and equipment; provide manufacturing engineering support to resolve production issues.
• Work with R&D and other cross functional teams to successfully transfer new products into
production and ensure that design for manufacturability principles are applied to new processes.
• Interact and coordinate activities such as CAPA investigations, and NCRs with Production and QC/QA personnel.
• Ensures processes and procedures are in compliance with GMP and GAMP regulations.
• Leads manufacturing engineering project plans by utilizing project management skillsets that include creating timelines.
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.
Others Information as per Local Legal Requirements
We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.
This contractor and subcontractor shall abide by the requirements of 41 CFR 60-1.4(a), 41 CFR 60-300.5(a) and 41 CFR 60-741.5(a). These regulations prohibit discrimination against qualified individuals based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity or national origin. Moreover, these regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
DiaSorin Inc and DiaSorin Molecular LLC are Affirmative Action and Equal Opportunity Employers. 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.
Equal Employment Opportunity
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