Validation Analyst--Lab Instruments
Seattle, WA

Job Description

Job Description:

* The validation analyst will provide an advisory role as needed. This may include:

o Advising clients on assigning proper risk to Lab Equipment

o Advising clients on how to meet compliance requirements.

o Advising clients on developing test that provide adequate compliance coverage as well as thoroughly tests business requirements.

* Responsible for performing validation of Laboratory Instrumentation by following approved standard operating procedures (SOPs), current Good Manufacturing Practices (GMPs) and all other regulatory requirements.
* Work with client to develop validation plan to ensure that, at the end of the project, the system meets FDA compliance requirements.
* Work with client business functions and subject matter experts to develop User Requirements, Functional, and Design Specifications to establish hardware/software requirements
* Develop test / validation scripts based on software / hardware design / configuration
* Develop Installation tests / qualifications scripts based on Design
* Develop Operation tests / qualifications scripts based on functional requirements
* Develop Performance tests / qualification scripts based on configuration
* Interact in a team environment, managing tasks and escalating issues as needed.

Job Knowledge/Skillsets:

* Fluent knowledge of rules and regulations: GAMP 5, CFR Part 11 Compliance and CFR Part 210, 211 Compliance.
* Fluent in Microsoft Office suite Including (Excel, Power Point, Visio, Project)
* Ability to work independently.
* Strong organizational/ facilitation/communication skills.
* Strong verbal, written and presentation skills.

Education & Experience/Technical Competencies:

* University certificate or degree with a minimum of 5 years of related industry exp, or BS inTechnology & 2-3 years of exp.
* Minimum 3 to 5 years in pharmaceutical industry, focusing on Systems Validation.
* Thorough understanding of the principles of GAMP, SDLC methodologies and testing best practice.
* Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of systems.
* Expertise in use and validation of GMP systems