Process Development Engineer

Our client a world leader in diagnostics and life sciences is looking Process Development Engineer. Kindly have a look at the details below and let us know if you are interested.

Job Title: Process Development Engineer

Job Duration: Long Term Contract(Possibility Of Extension)

Location: Santa Clara CA

Company Benefits include:

Healthcare (Medical Dental & Vision)

Paid Sick leave

401k (with 2% employer match)

Responsibilities:

Technical Support:

Provide handson 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:

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 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:

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 noncompliance observations (for example Corrective and Preventative Actions (CAPAs) and NonConformance Reports (NCRs) and provide technical input as needed to remediate discrepancies

Support regulatory inspections and audits by providing technical expertise and documentation as needed

Formal Training/Education:

58 years in Medical Device or In Vitro Diagnostics

BS in relevant field.

Prior experience: Cartridge manufacturing microfluidic devices or DNA Sequencing is preferred.

If interested please share your update resume at /