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.
We believe in a respectful and supportive workplace that attracts and celebrates the uniqueness of a diverse workforce that represents our community and customers.
The Process Development Engineer Level II is responsible to develop automated processes that support the mass production of new and/or existing products. This role will create automated systems for mass production that integrate processes such as cutting/heat sealing, lamination, pick-n-place systems, assembly, ultrasonic welding, precision filling, capping, label placement and packaging.
Qualifications Experience Personal Strengths Mobility
5+ Years Demonstrated knowledge pharmaceutical cGMP of biotechnology products, aseptic processing, clean room environments required
3+ Years Medical products GMP manufacturing experience required
3+ Years Successful experience of leading multi-functional teams required
3+ Years Experience with development programs
3+ Years Experience in a variety of robotic weld applications
3+ Years Robot and PLC simulation experience
3+ Years Experience with field bus networks, serial communication and Ethernet communication
3+ Years Exposure to a wide variety of production machinery, industrial sensors, and equipment.
3+ Years Excellent communication skills both written and verbal
3+ Years Experience in fast-paced iterative design and manufacturing environments
3+ Years Experience solving complex problems with little to no supervision on schedule as an individual or as a member of an integrated team
3+ Years Ability to think critically, and demonstrated troubleshooting and problem-solving skills
3+ Years Excellent interpersonal, verbal and written communication skills
3+ Years Ability to function efficiently and independently in a fast-changing environment
Design, implement, and successfully scale-up automated and semi-automated solutions based upon sound engineering principles.
Lead initial equipment conceptual development and carefully balance product specifications, process requirements, layout complexity, cost, and lead-time limits.
Collaborate closely with site and global partners to define, develop and deploy automated processing technologies including equipment, single-use disposables and processes
Develop user requirements based on process, quality and fitness for use in a GMP manufacturing environment. Work with vendors, suppliers, and internal partners to translate specific requirements into functional and design specifications
Lead hands-on activities that support process development and process characterization, including drafting procedures, execution of prototype studies, authoring technical reports, and participating on multi-functional risk assessment teams
Support management in business case analysis for new projects which includes inputs such as current Vs. forecast capacity, standard cost analysis, and ROI.
Develop automated manufacturing processes by sourcing relevant technology and/or collaborating with automation vendors to design customized medical device manufacturing equipment to improve safety, quality, efficiency and cost within the manufacturing environment
Keep abreast of meaningful technical trends and developments and incorporates them into appropriate assignments
Lead the project management of automation development by using visual project management tools (MS Project, critical path analysis, etc.). Define, manage, and communicate project timelines and risks
Perform Design for Manufacturing DFM, Design of Experiments DOE and design/process Failure Mode and Effects Analysis (DFMEA/PFMEA)
Collaborate with the Industrialization team for the development of validation protocols as well as its execution and reporting (for installation qualifications, operational qualifications, performance qualifications and process validations).
Travel to the vendor sites as needed for equipment development, FAT, or to drive project timeliness.
Use CAD to design/review/update tooling and fixtures.
Responsible for enforcing all EHS policies in their span of control.
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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