Software Validation Lead job Seattle Washington
Software Validation Lead job Seattle Washington
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Software Validation Lead Job

Employer Name: SpiderID: 8449150
Location: Seattle, Washington Date Posted: 2/28/2019
Wage: $90,000-$100,000 Category: Biotech
Job Code:
Number Of Openings: 1

Job Description:
We are seeking an experienced Software Validation Lead to join a fast-growing team.  The primary role of this position will focus on Validation of the genomics analysis software system and LIMS for both the US and international markets.  You will ensure the software meets global quality and regulatory requirements.  This software is an essential component of the “liquid biopsy” cancer diagnostic platform. Your contributions will help complete the transition from on-premises to; ready our software systems to meet important regulatory milestones; scale to meet 10x increase in patient/tests delivered over the next year; and add significant new capabilities. **RELOCATION AVAILABLE**

Responsibilities for the Software Validation Lead include: 

Manage validation/qualifications for Liquid Biopsy NGS pipeline and related software

Design, create, execute and approve Software Validation protocols for CFR 21 Part 11 Compliance – includes full life-cycle focused on the creation of software requirements, hazard analysis, testing and Validation

Communicate cross-functionally with engineering departments and perform ongoing research to assure that all devices are maintained for quality compliance.

Proven capabilities in creating validation documentation, including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, IQ/OQ/PQ Protocols, Reports, Trace-ability Matrix, and Standard Operating Procedures

Experience with systems including (but not limited to) on-premise and cloud solutions such as, LIMS, Veeva, Clinical Databases, EDC; as well as networks/infrastructure and hardware qualification

Demonstrated experience planning and scheduling validation and validation life-cycle deliverables, test execution, and deviation management

Share best practices, industry knowledge, and personal expertise to educate both clients and fellow consultants, in formal and ad hoc settings

Job Requirements:
BS Degree in Software Engineering, Biomedical Engineering, or Computer Science. In place of degree, 10 years of applicable work experience and professional certifications may be considered.

Minimum of 7 years Software
Development or Software Quality Engineering experience within an FDA-Regulated, Medical Device,
Pharmaceutical, Biotech, or other regulated industry.  CFR 21 Part 11 and IEC 62304

Advanced knowledge of IT systems, preferably in the Engineering environments.

Experience with managing Virtual Machine systems and basic server administration.

Experience with any of the following Software Languages: C , C#, Java, Visual Basic and HTML

Job Criteria:
Start Date: ASAP
Position Type: Full-Time Permanent
Years of Experience Required: 7
Education Required: Bachelors
Overnight Travel: None
Vacation Time:

Job Benefits:
Health/Dental Benefits, Stock or Stock Options, Paid Holidays, Vacations, and Sick Leave, Relocation Assistance, Offers Sponsorship for U.S. Visa

Company Profile:
The company is a global leader in Liquid Biopsy diagnostics using a Non Invasive method, which until now, has never been done. They are passionate about improving the lives of Cancer patients. If you are wanting to join a cutting-edge team, with competitive salary, great benefits and a fun work environment – this is a great role for you!

Contact Information:
Contact Name: Hayley Johnston Company Type: Recruiter
Company: Skills Alliance
City: Seattle
State: Washington
Zip: 98101

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