Process Development Engineer Job at Roche and Genentech, Santa Clara, CA

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  • Roche and Genentech
  • Santa Clara, CA

Job Description

Description:

Onsite Position 
Relevant Experience: 5-8 years in Medical Device or In Virtro Diagnostics
Education: BS in relevant field.
Prior Experience: Cartridge manufacturing, microfluidic devices or DNA Sequencing is preferred.

Technical Support:
● Provide hands-on process support including troubleshooting and improvement initiatives
● Support effort to characterize existing processes for production and testing - time, Overall Equipment Effectiveness (OEE), optimization and cost saving initiatives
● Create and approve Work Instructions, Production Records, and other documentation for processes; Managing change control for updates to production documentation
● Maintains processes utilized for production and testing to ensure process maps are up to date and process risk documents are updated to represent current controls
● Participate in project teams to define and monitor process health metrics (KPIs, key performance indicators)
● Partner with functional subject matter experts to support material qualification, supplier qualification, and actively manage issues found with incoming materials
● Support development of Qualification and Validation plans and take an active role in protocol executions

Continuous and Process Improvement:
● Actively seek opportunities to optimize process performance leveraging key performance indicators and lead important strategic process improvement projects to drive down costs and improve product quality
● Partner across the Roche network to build relationships with the goal of leveraging best practices in production and testing excellence (i.e. LEAN practices and Design for Quality and Manufacturability)
● Assess and provide technical input on continuous improvement initiatives and inventory optimization

Quality Mindset
● Partnering with MSAT colleagues and Operations Quality Stakeholders to maintain the qualified state of existing
processes
● Evaluate, advise, and ensure compliance for quality testing methods to optimize time, cost, and effort needed to execute necessary methods - advise on improvements and ensure controls are demonstrated through completion of method validation, spreadsheet validation, or computer system validation
● Ensure continuous monitoring for processes per quality system requirements to demonstrate ongoing compliance
● Support or lead investigations for identified non-compliance observations (for example, Corrective and Preventative Actions (CAPAs) and Non-Conformance Reports (NCRs)) and provide technical input as needed to remediate
discrepancies
● Support regulatory inspections and audits by providing technical expertise and documentation as needed

This is the pay range that Magnit reasonably expects to pay for this position: $56.00/hour-$63.00/hour

Benefits: Medical, Dental, Vision, 401K (provided minimum eligibility hours are met)

Magnit has an ongoing commitment to the diversity and inclusion of all team members. We believe that embracing diversity leads to innovation and helps address the needs of the business. We welcome individuals from different backgrounds, experiences, and cultures to join our team. We value this diversity and strive to create an inclusive environment that celebrates these unique perspectives, allowing you to contribute to your full potential. Finally, but most importantly, we expect all team members to be treated with dignity and respect.

If you have a disability and need an accommodation in relation to the online application process, please email us at Roche.Accommodations@magnitglobal.com

Job Tags

Contract work,

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