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Posted: Monday, January 8, 2018 3:20 AM

Juno Therapeutics is a clinical-stage company developing novel cellular immunotherapies based on two distinct and complementary platforms Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body's immune system to treat cancer.

Within the Validation team at Juno dedicated computer validation roles are providing qualification approaches and expertise as Juno implements critical GxP electronic systems and automates manufacturing, quality and business processes. The Senior Computer Systems Validation Engineer will lead qualification efforts associated with automated manufacturing and batch processing solutions, including electronic batch record (eBR) implementation and integration of manufacturing systems. This role will be instrumental in developing flexible and scalable systems in support of a multi-product GMP facility.

Key deliverables will be the generation of qualification plans, development and execution of qualification testing, and authoring of reports for multiple and concurrent projects. Collaboration with IT business partners and Quality Assurance will be critical to establish program guidelines and present the program in regulatory filings and audits. Current pharmaceutical/medical device experience including risk-based approaches, industry best practices and application of guidance (e.g. GAMP 5) will be advantageous in this role.

Job Description:

* Author computer validation plans, and associated protocols and summary reports

* Implement SOPs and procedures to govern automated system implementation and recipe management

* Develop testing and risk assessment strategies to support intake of new products and processes

* Project management, including oversight of contract resources and vendor deliverables

* Facilitate pre-qualification activities with internal system owners, including user requirements development and risk assessment

* Maintain programs to ensure data integrity and compliance with 21CFR Part 11

* Provide Quality Systems support by assessing change control impact to qualified systems and supporting investigations for system related deviations

* Represent the department on cross-functional project teams

Basic Qualifications:

* BS in an engineering or computer discipline with 7+ years of computer validation experience

* 3+ years relevant biopharmaceutical industry experience

* Experience with the following system types is highly desired: MES/EBR (Emerson, Werum or Rockwell), PLC/DCS (DeltaV preferred), data historian

* Knowledge of computer systems lifecycle and compliance requirements to support GMP manufacturing, testing and distribution of product

* Excellent written and verbal skills, ability to clearly define written requirements is essential

* Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects

Preferred Qualifications:

* Experience using ValGenesis software for validation document development and execution is preferred

* Strong technical understanding of biopharmaceutical systems, equipment, and processing techniques

THINK BIG. BE BRAVE. DELIVER.

SDL2017


Associated topics: asic, chip, digital, engineer, engineer iii, hardware designer, ic, pc, semiconductor, vlsi

Source: http://www.jobs2careers.com/click.php?id=4704636712.96


• Location: Bothell, Seattle

• Post ID: 60913587 seattle
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