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COMPUTERISED SYSTEM VALIDATION ENGINEER
COMPUTERISED SYSTEM VALIDATION ENGINEER
INTERSURGICAL, UAB
COMPUTERISED SYSTEM VALIDATION ENGINEER

COMPUTERISED SYSTEM VALIDATION ENGINEERINTERSURGICAL, UAB

Responsibilities:

A person in this role will be responsible for validation of computerised systems, which support various production and quality management areas

Main responsibility:

• Maintain validation projects, associated to computerised systems, from an initiation to a closeout.
• Participate in a review and development of requirements and specifications for computerised systems.
• Participate in a risk management process, aimed for eliminating or reducing risks associated with automation / software, identify and suggest appropriate controls.
• Develop and maintain project plans, testing/verification protocols, reports and other deliverables within the scope of validation project;
• Execute planned tests/verification, collect and document results;
• Document any deviations encountered while executing tests/verifications, plan and document corrective actions.
• Ensure that the systems validation state is maintained after a release by performing a periodic and a non-periodic review and re-validation, when required.
• Work in liaison with a project specific team, that includes multiple members from IT and end-user departments, to ensure validation activities are completed in expected timelines.
• Participate in improving validation methods, team collaboration and testing/verification tools.

Basic Qualifications:

• Bachelor’s degree (preferably in Engineering, Mathematics, IT or other exact sciences discipline);
• Good verbal and written communication skills in English & Lithuanian;
• Ability to work and interact with various personnel;
• Good computer knowledge: MS Word, MS Excel, MS Outlook

Preferred Qualification:

• Planning, organizational and project management skills;
• Basic understanding of manufacturing and/or quality management processes.
• Knowledge of cGMP regulations.
• Understanding of software development life-cycle, desktop, web based applications and SQL database;
• Experience in computerised system validation, software testing or similar area.

We offer

• Interesting and challenging work;
• Competitive salary from 1500 to 2000 Eur (gross) (depends on background and experience);


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Confidentially is guaranteed. Please send your CV marked “Validation engineer (computerised systems)” until 2022-06-30 by info@intersurgical.lt, or Personnel department, UAB Intersurgical, Arnionių 60/28-1, 18170 Pabradė.

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