Job description

What if every day you could wake up, excited to come to work, knowing YOU can impact the the future for a patient waiting for a life-changing/saving treatment? At GenMark/Roche we are grateful to work with amazing colleagues to pursue that mission. We are passionate about the science, embracing creativity, agility and quality in all we do. We pride ourselves on an inclusive atmosphere where diverse ideas, backgrounds and viewpoints are valued. AND we have fun doing it! Thinking of GenMark/Roche as the next step in your career journey? Then check out our current openings -- because making a difference in the lives of millions starts when you make a change in yours.

• Troubleshoot Mechanical, Electrical and Software related issues on GenMark’s ePlex Cartridge and Consumable manufacturing equipment
• Make necessary repair and/or adjustments to manufacturing equipment with minimal engineering supervision
• Perform assigned Preventive Maintenance on production equipment as well as maintain manufacturing and R&D equipment and instruments to the manufacturers’ specification
• Train all junior technicians in the theory and operation of all equipment
• Recommend solutions to recurring issues and partner with Manufacturing Engineering to implement solutions
• Support Manufacturing Engineering group with continuous process improvements projects and make recommendations to improve process and reduce scrap.
• Execute equipment validations (IQ/OQ) and document all activities following Good Documentation Practice
• Document Equipment and Engineering activities in accordance with established procedures, company policies and FDA
• Assist with process improvement projects as directed to include the spare parts program, fixtures needed to support manufacturing, R&D, and other company needs
• Good facilitation, communication, self-discipline, teamwork, and task organizational skills
• Apply basic electronic theory to troubleshooting efforts
• Assist junior technicians in basic troubleshooting efforts, GDP compliance and understanding
• Follow clean room procedures, and assist junior technicians in understanding and compliance
• Contribute to culture of electrical safety, and assist junior technicians in understanding and compliance
• Identify and lead special projects and perform additional duties as assigned

POSITION REQUIREMENTS

• High School Diploma is required with at least 5 years of experience in a regulated manufacturing environment is preferred
• Associate degree with at least 3 years of experience in a regulated manufacturing environment is preferred
• Strong quality-orientation with attention to detail and a desire to deliver service excellence is essential
• Asset Database Management system experience required
• Knowledge of CGMP, FDA 21 CFR-Part 820 required
• Strong problem-solving, judgment and decision-making skills
• Must be experienced with the use of computer software programs such as Word, Excel
• Direct hands-on experience in maintaining electro-mechanical equipment
• Demonstrated ability to analyze and troubleshoot both mechanical and electronic systems
• Demonstrated ability to analyze equipment faults and provide a root cause
• Knowledge and experience with laboratory diagnostic instrument software and systems
• Experience using documents and quality control procedures which include best practices
• Experience with automated liquid reagent dispensing systems (Biodot, etc..) a plus
• Experience with surface modification (plasma, Corona, etc..) and spray coating a plus
• Experience with machine vision system (Cognex, Keyence, etc.) a plus

WORK ENVIRONMENT

The essential functions of the job are usually performed in an environmentally controlled facility where the noise level in the work environment is usually moderate. This position may involve a combination of office and biotechnology laboratory environments. The employee may be exposed to hazardous chemicals, blood borne pathogens and automated equipment.

While performing the job duties, the employee is regularly required to sit; reach with hands and arms and talk or hear. The employee is frequently required to stand and walk. The employee may sometimes be required to lift and/or move up to 35 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and ability to adjust focus.

*Relocation assistance is NOT available for this role*

The expected salary range for this position based on the primary location of California is $53,200.00 to $98,800.00. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits Link: https://roche.ehr.com/default.ashx?CLASSNAME=splash

Job Type: Full-time

Pay: $53,200.00 - $98,800.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Tuition reimbursement
• Vision insurance

Experience level:

• 5 years

Work Location: In person

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