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Location

Carlsbad, CA | United States

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Job description

Process Engineer I - Night Shift Location Carlsbad, CA (North Beach area) : The Position

Always innovating, we bring together dedicated people and diverse perspectives from across our global network, empowering each other to keep breaking new ground. We are Roche.

The team, GenMark Diagnostics is a leading provider of multiplex molecular diagnostic solutions designed to enhance patient care, improve key quality metrics, and reduce the total cost-of-care. At GenMark, we're changing the diagnostics landscape, combining out-of-the-box thinkers and game-changing technology to revolutionize patient care. Our work atmosphere is dynamic, fast-paced, and patient-focused. We encourage teamwork, while reinforcing the importance of individuality, and encouraging an entrepreneurial spirit

Your Opportunity

The work schedule for this position is a night shift from Sunday through Friday from 10 PM to 6:30 AM.

As a Process Engineer you are responsible for driving stable, reliable production processes. You are instrumental in troubleshooting, testing , and supporting for existing products and new product lines. Under minimal supervision, you will apply engineering principles to resolve complex manufacturing equipment issues that arise and implement initiatives to reduce equipment downtime and improve throughput yields.

Also, you are:

• Investigating, troubleshooting, and resolving issues that arise within the manufacturing process and effectively communicating findings in a timely manner. Assist with problem solving and root cause analysis using tools (ex. 5 WHY, Fishbone Diagram…etc), DOEs (Design of Experiments), data analysis, and development/implementation of sustainable countermeasures.
• Applying statistical methods to various production performance datasets to monitor, track and trend, and/or assess opportunities for improvement in capacity, yield, and/or utilization.
• Executing validation (IQ/OQ/PQ) protocols, test method validations, test protocols, and associated activities for new or improved processes and manufacturing equipment.
• Participating in project teams as part of product improvements, automation, and quality improvements. Also, you are supporting process development, characterization & improvement activities to both new and existing product lines. To ensure project success, we apply standard project management tools and principles
• Serving as advocate and role model for integrating change into the organization as well as serve as departmental role model of professional behavior and presence. You are training manufacturing and maintenance personnel as needed.
• Document management: You will create, and approve Product BOM's, Specs, Work Instructions and other documentation as part of the Design Transfer for new product introductions.

Who you are

• As an ideal candidate, it is preferred that you hold a Bachelor's degree in Engineering or a related technical discipline and bring 1+ years of related industry experience and background,
• Equivalent industry experience (5+ years) with a high school diploma is acceptable.
• The experience you bring is in designing/implementing manufacturing processes, equipment and fixtures.
• It's strongly preferred that, you are knowledgeable of pharmaceutical/medical device cGMPs and FDA compliance
• Other pluses: Experience with design transfer activities for medical devices and designing/implementing automation equipment

Behaviors, competencies, and qualities

• Support cross-functional teams in problem solving, development of improvement plans and root cause analysis.
• Must be proficient in the use of SolidWorks or equivalent CAD software, Word, Excel, Visio, PowerPoint.
• Familiarity with experimental design, data analysis, and interpretation of experiments; Proficient in the use of statistical software such as JMP is plus.
• Strong quality orientation and a desire to deliver service excellence. Familiarity with Lean Six Sigma or Six Sigma DMAIC methodology is a plus.
• You have great organizational skills in a dynamic, constantly changing environment. You are an effective communicator for sensitive inquiries, customer inquiries or complaints as well with management, peers, and individuals. You can work effectively, exhibit a professional manner and establish constructive working relationships.
• You will be able to think and work both tactically and strategically to provide financial and operational needs to GenMark's business.

Relocation benefits are not offered for this job posting

The expected salary range for this position based on the primary location of Carlsbad, CA is $65,200-$121,000. 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

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.

Who we are

GenMark is now a proud member of the Roche Group, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. As a global leader in healthcare, Roche Diagnostics offers a broad portfolio of products, tools and services that help in the prevention, diagnosis and management of diseases like HPV, HIV, hepatitis and diabetes as well as other medical conditions, such as fertility and blood coagulation. With the addition of GenMark to the Roche Group, syndromic infectious disease diagnostics is now added to the long list of disease states and conditions that the Roche Group addresses. GenMark's ePlex true sample-to-answer system offers unique solutions to address the most significant challenges facing clinical laboratories, while supporting hospital systems to deliver patient-centered, value-based care. ePlex streamlines the diagnostic workflow from physician order entry to the final test report and is the true sample-to-answer solution designed to improve patient care, reduce costs, and increase lab efficiency. GenMark is headquartered in Carlsbad, California.

GenMark is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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