Quality Validation Engineer

hace 1 mes

Barcelona, España Ecolab A tiempo completo

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

Our Commitment to Diversity and Inclusion

Ecolab is committed to fair and equal treatment of associates and applicants and furthering the principles of Equal Opportunity to Employment. Our goal is to fully utilize minority, female, and disabled individuals at all levels of the workforce. We will recruit, hire, promote, transfer and provide opportunities for advancement based on individual qualifications and job performance. In all matters affecting employment, compensation, benefits, working conditions, and opportunities for advancement, Ecolab will not discriminate against any associate or applicant for employment because of race, religion, color, creed, national origin, citizenship status, sex, sexual orientation, gender identity and expressions, genetic information, marital status, age, or disability.

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