Process Engineer II - Night Shift

Company: Disability Solutions
Location: Carlsbad
Posted on: April 20, 2024

Job Description:

Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.The PositionAlways 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 spiritYour OpportunityThe 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 will be driving stable, reliable production processes for new manufacturing processes recently transferred to production. Under minimal supervision, you will use sound and proven engineering principles to develop and characterize manufacturing processes, including surface treatment (i.e. plasma, CO2 cleaning) and precision dispensing of fluids and adhesives. In this position, you will be instrumental in creating and maintaining process input and output specifications, performing capacity analyses, troubleshooting, testing, and support for existing products and new product lines. This position will sustain and continuously improve process for existing products. 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
  • You have a Bachelor's degree in Engineering or related technical discipline with 4+ years of related experience, background and industry, or M.S degree with 2+ years of related experience, background and industry. Equivalent industry experience (5+ years) with a high school diploma is acceptable.
  • You bring experience 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 equipmentBehaviors, 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 California 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.Work EnvironmentThe 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 areGenMark 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.

Keywords: Disability Solutions, San Marcos , Process Engineer II - Night Shift, Engineering , Carlsbad, California