Offers “Roche”

Expires soon Roche

Senior System/Process Engineer

  • Santa Clara (Santa Clara)
  • Sales

Job description

·  Job facts

Summary:

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Join our team as a Senior System/Process Engineer and use your expertise to work with diverse teams of engineers, project managers, and business partners to ensure our projects follow our processes in an efficient and effective manner from project planning and execution to deployment.

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We are looking for a self-motivated process engineer to successfully implement the design control process for several systems in development. This position requires performing process gap assessment, implementing solutions, coaching and training system teams on process execution as well as authoring and releasing project documentation, Standard Operating Procedures (SOP's), work instructions, training material, and templates. This will be a “hands-on” role accountable for compliance to Roche processes during the development process.

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A successful candidate will participate in the development of state of the art sequencing and sample preparation systems. This will require a deep understanding of the technology. Activities will include technical contributions in addition to assuring compliance with Roche protocols.

Job Responsibilities

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Participate and lead cross-functional teams of multiple disciplines representing different stakeholders in implementing and executing development processes.

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Contribute to the development of the systems by participating in the integration activities. This includes system integration, characterization, optimization and verification.

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Author and release documentation. Maintain the Design History File records for systems in development. Manage knowledge transfer with Subject Matter Experts (SME's) from a range of disciplines.

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Troubleshoot and resolve processes and documentation issues as a subject matter expert. Work closely with dQA, Diagnostic Standards and Interoperability, and process experts to assure development activities conform to Roche standards.

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Oversee and manage communication with collaborators outside of the development team.

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Track deviations and participate in the optimization of development processes.

Qualifications

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BS or equivalent with 5+ years related experience or MS with 4+ years related experience.

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Experience in hardware development in a regulatory environment

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Strong analytical skills

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Strong communication skills

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Preferred: 3+ years process development work experience or equivalent

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Preferred: Familiar with the Standards, Regulations, and FDA Guidance documents (ISO 13485, 21CFR Part 820, IEC62304, TIR45)

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Communicate clearly and effectively with engineering colleagues, project managers, and project teams on a daily basis through email, telephone, and face-to-face meetings.

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Works independently, establishing work priorities and direction

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Ability to evaluate and analyze procedural gaps

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Ability to persuade others to change existing practices

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Strong attention to detail

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Proven ability to identify, assess and solve problems

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Proficient with computer and information technology

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Knowledge of process engineering software systems

Roche 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.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at US.Accommodation@roche.com .

·  Who we are

At Roche, 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche 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.

Make every future a success.
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