The Opportunity

 

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic.

Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all.

The Role

As we continue to grow, we are seeking an Electro-Mechanical Technician III.  This role requires knowledge and maintenance of manufacturing equipment in a production environment.  The individual we seek will identify issues, define solutions and maintains process/packaging equipment using cGMP best practices.  The individual will maintain compliance with all company quality, safety, and regulatory procedures.  The individual will expand his/her knowledge of the medical device industry while delivering a high level of customer service. 

The position will require extended hours and weekend work as needed.

This is a first shift position and will be located in Raritan, NJ.  

The Responsibilities

Perform preventative, corrective and emergency maintenance and troubleshooting of packaging and processing equipment through the application of problem-solving tools within the Ortho Raritan Facility.  Equipment on site includes fillers, labelers, plate coating equipment, overwrappers, autoclave, oven, incubators, torque testers, scales and printers.  Note:  This list is not all inclusive. 

Detect, define, investigate, and resolve production equipment related failures to improve productivity.  Review equipment manuals to troubleshoot manufacturing equipment issues as they arise. 

Strong electrical, mechanical and machine control skills (through the use of programming terminals) are required.

Working productively with minimal supervision, while responding to maintenance requests.

Research and recommend electrical and mechanical parts purchasing. Research and select compliant electronic devices to replace obsolete items.

Reviews equipment, parts and supply inventories by checking stock to determine inventory level.  Anticipates needed equipment, parts and supplies and places orders, sometimes expedited. 

Provide accurate documentation of all activities associated with maintenance work orders, maintenance follow up, and part retrieval. Accurately complete documentation of maintenance work performed in GMP documents and computerized maintenance management system (CMMS) or calibration program.

Provide the manufacturing team direct support in routine problem solving of a moderate to complex nature and identifying and correcting issues. 

Assist in setup and operation of production equipment and troubleshoot equipment in cleanroom and non-cleanroom environments.  Operate production equipment according to standard operating procedures.

Take necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors.

cGMP responsibilities will include support of non-conformance investigations related to process and facility equipment problems and corrective/preventive actions.

The Electro-Mechanical Technician III – Controls will directly support engineering projects, validations, and process improvement projects. 

Ensure customer satisfaction through consistent follow-up and close-out of maintenance activities with client base. 

Fabricate repair parts by using machine shop instrumentation and equipment.

Download, upload and back-up equipment programs and maintain catalog of files. 

Performs duties with minimal direction or supervision, self-starter.

There are occasional interactions with internal and external regulatory agencies.

Ability to share and receive knowledge with team members.

Assist in the planning and implementation of new process equipment and upgrades using feasibility studies which include development of options and the analysis of alternatives. 

Assist with developing and implementing change control documentation to update preventive maintenance procedures, standard operating procedures (SOPs), and installed equipment files in accordance with cGMP practices.

The Individual

Required:

Technical associates degree or equivalent.  Must have 8 years of experience in a manufacturing environment.

Working with a formalized computerized maintenance management system (CMMS) or calibration program.

Less than 10% travel

Must have excellent oral and written communication skills

Strong technical aptitude and computer knowledge demonstrated ability to learn and resolve technical issues

Builds trust and relationships

Implements change and modifies work approach to deliver expected results

Possess good planning and organizational skills  

Ability to keep multiple jobs in controlled motion, self-motivated

Must be knowledgeable of automated packaging equipment including knowledge of electrical, controls (i.e. HMI, PLC) and machine setup

The successful candidate should be knowledgeable of computer-based machine control, PLC programming, servo motors, automated filling and inspection systems (i.e. vision systems)

Must be proficient with MS Office WORD and EXCEL software and be able to learn/utilize CMMS (MAXIMO) software

Must be able to interpret blueprints, shop drawings, and follow process and electrical drawings, diagrams, sketches, operations manuals, manufacturer's instructions, and engineering specifications

Preferred:

Experience with GMP, ISO, and calibration requirements

Knowledge of FDA and EU regulations

Ability to examine the equipment to be maintained and determine the appropriate preventative maintenance including spare parts handling and documentation

Experience in troubleshooting, adjusting, downloading, uploading and backing up automated machine controls and PLC’s/industrial computers

Experience in the use of multimeters or other diagnostic devices to aid in troubleshooting activities

Familiarity with Electrical Safety requirements such as 70E

Ability to read and understand ladder logic and PLC programs for modification and troubleshooting, especially Allen-Bradley products

Familiarity with electrical parts and wiring conventions and ability to make wiring changes

The Work Environment

The work environment characteristics are representative of an office, manufacturing and clean room environment.

The Physical Demands

Physical and work condition demands of the position include: Some lifting, not to exceed 50 pounds. Manual dexterity for handling instruments and repetitive motions, sitting and standing for a long period of time. Working conditions include sitting, standing, walking, climbing ladders, working on hands and knees, in cramped or awkward positions and in confined areas. Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position. Ability to work in bio-hazard areas and clean rooms.  Bio-hazard areas require the use of protective gear and on-going monitoring. Must wear protective clothing and safety equipment, as required. Must be able to work off-shifts and extended hours. Required to participate in 24/7 emergency on-call coverage and weekend overtime work as per production schedules. 

Salary Transparency

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $68,000 - $85,000 annually. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

Equal Employment Opportunity

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at recruiting@quidelortho.com.

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