Maintenance Engineer Technician

Published on: Oct 3, 2024

Country: United States

Location: Cypress, California

Company: DiaSorin Molecular LLC

Job Category: Operations

Employment type: Regular Full Time

Req ID: 6499

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, we've 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 that's 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 you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're 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 that's 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!

SUMMARY

Apply fundamental maintenance practices to support the reliability, and availability of equipment. Proven skills in the areas of equipment maintenance, automated control systems, and preventative maintenance. Able to collaborate with vendors, suppliers, and internal cross-functional teams to ensure effective validation, maintenance, and calibration of critical equipment per cGMP. Responsible for evaluating and maintaining equipment/processes to improve quality, consistency, and productivity. Support company goals, policies, and procedures while complying with applicable regulations. Responsible for assisting or leading the development and performance of validations on equipment. Supports all applicable regulations including but not limited to FDA, ISO, IVDD, and IVDR requirements.

ESSENTIAL DUTIES & RESPONSIBILITIES

Support initiatives to improve production processes to grow productivity, increase manufacturing yields, reduce production costs and decrease scrap. Collaborate with manufacturing engineering on automation projects to improve quality and manufacturing efficiency.

Support manufacturing engineering in the development of equipment URS (user requirement specifications), as well as the development, execution, and reporting of validation protocols (for installation qualifications, operational qualifications, performance qualifications, and process validations).

Utilize DiaSorin’s asset management system to ensure the maintenance system is compliant with cGMP, DiaSorin’s quality system, and related regulations. Responsible for utilizing periodic maintenance and calibration schedules.

Perform preventive maintenance and calibrations on equipment per asset management schedules. Perform updates in the asset management system to record all work performed. Use the asset management software to create progress reports for management.

Perform hands-on mechanical and electrical repairs to production equipment in a safe, timely, and precise manner.

Troubleshoot manufacturing processes/equipment and provide manufacturing engineering support to resolve production or equipment issues. Support efforts to perform root cause investigation, troubleshoot issues and address root causes. Sustain record integrity of all issues and resolutions in the asset management system.
Support the development of manufacturing processes by recommending equipment purchases, repairs, upgrades, obsolescence, best practices, and maintenance schedule changes to improve efficiency and cost within the manufacturing environment.
Support Maintenance Engineers in supervising visits from service contractors to perform repairs, maintenance, and calibration.
Proficient at using dial indicators, calipers, micrometers, and other precision measuring devices.
Familiarity with equipment drawings and manuals to be able to make adjustments and repairs or perform preventative maintenance as needed.
Responsible for performing assigned tasks in accordance with the company’s quality policies and procedures per the applicable quality management system regulations as defined in the Quality Manual.
Responsible for performing assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies. Violations of EHS regulations or policies will be handled in accordance with the established Company disciplinary process.
Perform other duties as assigned.

EDUCATION AND/OR EXPERIENCE

Five plus years of experience in manufacturing/production environment required.
Experience in in vitro diagnostics manufacturing, medical device manufacturing, pharmaceutical manufacturing, or other related industry is a plus. Cleanroom experience strongly preferred.
Extensive experience in process automation, equipment design, validation, and hands-on maintenance. A thorough understanding of quality control, process control, corrective actions and their application as a problem identification and resolution tool.
Good documentation practices of work performed is a must. Proficient in PLC troubleshooting is a plus. Computer skills in Microsoft Office applications, asset management software (Blue Mountain), ERP software (SAP), CAD software (SolidWorks/Autocad/Creo), and MINITAB is preferred. Experience with Reliability Centered Maintenance is a plus.
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.

LANGUAGE SKILLS

Ability to comprehend and communicate (orally and written) in English.
Proficient in technical writing. Ability to write clear, concise, and complete communications in regards to work that was completed and any additional work still needed
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, including managers, clients, customers, vendors, and the general public.

MATHEMATICAL SKILLS

Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume.
Ability to apply concepts of basic algebra and geometry.

REASONING ABILITY

Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.

PHYSCIAL DEMANDS

While performing the duties of this job, the employee is occasionally required to stand, walk, sit, use hand to finger, handle, feel, reach with hands and arms, climb or balance, stoop, kneel, crouch, or crawl, talk and hear.
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.

OSHA RISK CATEGORY

Category 2 (Medium Risk) due to machinery, electrical systems, and chemicals and independent functioning.

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 hrtalent@diasorin.com or 1-800-328-1482 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.