What are the responsibilities and job description for the Validation Engineer position at Compunnel Inc.?
Job Description
- 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.
- Have solid oral and written communication skills and teamwork skills.
- 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 business representatives to ensure the test cases reflect business rules and processes.
- Fulfills a subject matter expert role(s) for critical quality and compliance GxP end-use applications supporting Animal Health business processes.
Skills : Required Experience
Education :
