CSV Engineer (Computer System Validation)

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Company: Katalyst HealthCares and Life Sciences

Location: Kansas City, MO 64118

Description:

Roles & Responsibilities:

Validation documentation Authoring (validation plans, user requirements specifications, risk assessment, IQ-OQ-PQ protocols, trace matrix and summary reports).
Experience in validating GMP Lab systems and Equipment.
Responsible for assuring a system/application meets its requirements as outlined in system specification (URS/FRS) per process defined in the Validation Plan for the project.
Identify and escalate, as necessary project risks and issues to the CSVC Manager.
Engage in multiple CSVC projects through the assimilation of data, establishing facts and drawing valid conclusions to deliver results in accordance with resources, constraints, and business needs.
Be able to prepare reports on defects and problems that arise during system testing.
Be a good team player, able to meet deadlines and handle changing priorities.
Have strong judgment capabilities to clarify requirements when necessary.
Have the ability to work with cross functional teams.
Have solid experience working with validated systems.
Work with system owner to ensure the test cases reflect system functionality and intended use.

Requirements:

BS in Science or Technical Writing Degree.
GMP/Regulated lab, more than 5 years of CSV experience required.
Technical writing Experience.
Highly skilled in Computerized System testing and validation in the healthcare industry.
Knowledge of GxP regulations (e.g. 21 CFR Part 11, Annex 11).
Solid project organizational skills. Ability to multi-task.
Must have strong analytical problem-solving skills.
Excellent communication including written, verbal, and listening skills.
Self-motivated, detail oriented, takes initiative and ability to work independently without close supervision.