Quality Validation Engineer (Computer Systems Valdiation)

Job title:

Quality Validation Engineer (Computer Systems Valdiation)

Company:

Ecolab

Job description

At Ecolab we are looking for a Quality Validation Engineer (Computer Systems Valdiation) to join our Computer Software Assurance & Validation Team.What You Will Do:

• Lead or assist in business risk/impact determinations to determine when validation is required.
• Develop internal/external connections with development, implementation and business teams to provide CSV expertise and deliverables for new system deployments and rolling out future enhancements.
• Develop and manage computer software validation deliverables for large and small computerized systems and automated equipment systems.
• Ensure the application of Computerized System Validation best practices, ensuring systems meet industry standards before launch.
• Ensure and support the lifecycle approach and risk-based approach to system validation is integrated for systems and business units.

Minimum Qualifications:

• Bachelor’s degree in Engineering (preferably Software, Industrial or Systems)
• Minimum 3 years of experience in quality or engineering roles.
• 2-5 years of work experience in equipment validation and/or IT field associated with the implementation and validation of computer systems.
• Business Fluent in English (B2 – C1). Excellent written and oral communication skills.
• Lead and change management skills.
• Knowledge of FDA/EU regulatory requirements and industry best practices for computerized system validation to complete tasks
• Knowledge of FDA, ISO, GAMP practices, Software development life cycle and risk-based approach to validation

Preferred Qualifications:

• Experience in medical device or pharma fields.
• Experience with GxP (“Good x Practice”) compliance and related Quality & Manufacturing System regulations.
• Must have good interpersonal skills and the ability to work closely with cross-functional teams to document validation deliverables throughout the software development lifecycle and during the software maintenance phase.
• Experience in preparing, enacting, and driving different teams and ensuring deliverables conforming to various regulations.
• Experience in generating, reviewing and executing validation and change control documents, authoring Standard Operating Procedures (SOPs), and providing training on guidance and SOPs.
• Experience in driving adherence to QA and IT policies, procedures, industry standards and best practices.
• Effective oral and written communication skills, project management experience; organizational skills, attention to detail, and the use of good judgment in a fast-paced environment are essential.
• Demonstrated ability to stay current with best practices, existing and emerging technology platforms, architecture industry trends, and systems engineering.

Ecolab’s commitment to diversity, equity and inclusion (DE&I) reflects our longstanding value of working together to integrate diverse perspectives to challenge ourselves, reach our goals and do what’s right. Disability certificate will be an asset.#li-eu

Expected salary

Location

Barcelona

Job date

Wed, 09 Oct 2024 06:21:31 GMT

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