Job Title
Job Facts
Professional Family:
- Operations
Kind of contract
Job Scope
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.
Main Responsibilities
The Advanced Manufacturing Engineering team is responsible for the innovation of new production systems as well as the industrialization and sustainment of such systems.
This position supervises a team of engineers responsible for developing automated processes to
support the mass production of new and/or existing products and processes. Additionally, manages process improvement for mass production including cutting/heat sealing, lamination, automated pick-n-place systems, ultrasonic welding, lyophilizing, and precision filling and capping. Supports applicable regulations including ISO13485, Local, State, and/or Federal requirements.
Qualifications Experience Personal Strengths Mobility
An Advanced degree with 3+ years of experience
Medical products GMP manufacturing experience
Successful experience of leading multi-functional teams
Demonstrated knowledge pharmaceutical cGMP of biotechnology products, aseptic processing,
clean room environments
Ability to think critically, and demonstrated troubleshooting and problem-solving skills
Excellent interpersonal, verbal and written communication skills
Ability to function efficiently and independently in a fast-changing environment
Self-motivated and willing to accept temporary responsibilities outside of initial job description
Ability to read, analyze, and interpret equipment manuals, electrical/mechanical/P&I schematics,
general business periodicals, professional journals, technical procedures, and/or governmental
regulations.
Ability to write reports, business correspondence, manufacturing documents,
maintenance schedules, and standard operating procedures.
Ability to effectively present technical information and respond to questions from a variety of people that include managers, clients, customers, vendors, and the general public
Ability to read, analyze, and interpret equipment manuals, electrical/mechanical/P & amp schematics, general business periodicals, professional journals, technical procedures, and/or governmental regulations. Ability to write reports, business correspondence, manufacturing documents, maintenance schedules, and standard operating procedures. Ability to effectively present technical information and respond to questions from a variety of people that include managers, clients, customers, vendors, and the general public
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic
equations, and permutations.
Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory and factor analysis
Ability to handle and reason through complex information, define problems, collect data, establish facts, and draw objective conclusions
Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables
Supervise the design, implementation, and successful scale-up of automated and semi-automated
solutions based upon sound engineering principles
Supervise initial equipment conceptual development and carefully balance product specifications,
process requirements, layout complexity, cost, and lead-time limits.
Ensure team collaborates closely with site and global partners to define, develop and deploy
automated processing technologies including equipment, single-use disposables and processes
Lead and 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.
Bachelor's degree in Biomedical, Industrial, Chemical or Mechanical Engineering or equivalent
programs with 5+ years of experience
An Advanced degree with 3+ years of experience
Medical products GMP manufacturing experience
Successful experience of leading multi-functional teams
Demonstrated knowledge pharmaceutical cGMP of biotechnology products, aseptic processing,
clean room environments
Ability to think critically, and demonstrated troubleshooting and problem-solving skills
Excellent interpersonal, verbal and written communication skills
Benefits
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
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.
If you’d like to view a copy of the company’s affirmative action plan or policy statement, please contact us directly. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please call toll-free 1.800.328.1482.
Job Type: Full-time
COVID-19 considerations:
Throughout the pandemic we have taken guidance from federal and local public health agencies while continually assessing our protective measures. We encourage our employees to be vaccinated against COVID-19, and masks are required in this location.