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, California. 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, retains and celebrates the uniqueness of a diverse workforce that represents our community and customers.
The Maintenance Engineering and Metrology Manager will lead a team of maintenance engineers and calibration technicians for the molecular and consumable departments. Must be able to collaborate with vendors, suppliers, and internal cross functional teams to ensure the equipment is available and running at optimal conditions in order to support the production goals.
Qualifications Experience Personal Strengths Mobility
Collaborate with the innovation and industrialization team to design, implement and successfully scale automated and semi-automated.
Collaborate with Manufacturing Engineering for the execution and reporting of validation protocols (for installation qualifications, operational qualifications, performance qualifications and process validations).
Engage machine/automation suppliers for equipment troubleshooting and/or upgrades.
Own the spare parts management system to ensure key components are available for critical repairs.
Responsible for the development, planning and execution of all preventive maintenance and calibration for critical equipment.
Supervise the administration of DiaSorin’s asset management system to ensure the maintenance of all systems are compliant with cGMP
Responsible for creating, maintaining, and implementing production shifts, maintenance and calibration schedules.
Responsible for the Regulatory Asset Management system.
Bachelor’s degree in engineering (or other technical) discipline.
Experience in medical equipment asset management, CGMP documentation, laboratory equipment calibration, robotics/automation, equipment/process design and validation.
Proven ability for “hands-on” mechanical aptitude in automated systems, precision filling/capping, lyophilization, heat sealing, compressed air systems, tooling assembly, etc.
A thorough understanding of quality control, process control, corrective actions and their application as a problem identification and resolution tool. Proven ability in root cause analysis, failure mode effects analysis (FMEA), design of experiments (DOE), Six Sigma principles, and asset performance metrics.
Proven experience as a successful project leader and able to communicate across layers of the organization, including Executives members and shop floor technicians.
Experience in PLC troubleshooting is a plus. Experience in Control Systems such as Allen Bradley, Siemens, & SCADA systems is a plus.
Experience with Reliability Centered Maintenance is a plus.
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
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 Posters: https://www.dol.gov/agencies/ofccp/posters.
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