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
To help us track our recruitment effort, please indicate in your email/cover letter where (vacanciesineu.com) you saw this job posting.