CSV Engineer Computer System Validation
CSV Engineer Computer System Validation
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Salary Not Disclosed
1 Vacancy
Job Description
Responsibilities:
- Validation documentation Authoring (validation plans user requirements specifications risk assessment IQOQPQ 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 multitask.
- Must have strong analytical problemsolving skills.
- Excellent communication including written verbal and listening skills.
- Selfmotivated detail oriented takes initiative and ability to work independently without close supervision
Employment Type
Full Time
