Stiamo ricercando un profilo di: Computer Sistem Validation Engineer, preferibilmente locato nella Provincia di Roma.
Summary: This position uses policies and procedures to validate/qualify computer systems, including process automation systems, IS applications/infrastructure, and enterprise systems. Plans, coordinates, and participates in a compliant validation process for quality information technology and automation systems which require formal validation documentation under appropriate regulatory requirements and company manufacturing standards.
Essential Duties and Responsibilities include, but are not limited to, the following:
Prepares/reviews validation documentation related to projects/change controls.
Manages change controls and other compliance related tasks e.g. non-conformances.
Participates in the review of current and future CSV procedures and polices
Analyses the results of testing and determines the acceptability of results against predetermined criteria.
Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
Coordinates with other departments or outside contractors/vendors to complete validation tasks.
Participates in regulatory audits and communicates company’s computer validation policies.
Assesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps.
Manages projects and prepares status reports using Microsoft project and other communication tools.
May supervise, lead, or manage lower-level personnel.Agent expected skills: CSV , IT, GMP based knowledge.
Demonstrated ability with information technology delivery for regulated businesses highly desirable, specifically in supporting IT delivery or transition in manufacturing or integrations. Leadership experience in a matrixed environment preferred.
Ability to balance the long-term ("big picture") and short-term implications of individual decisions
Experience in delivery of successful enterprise level IT programs
Other Requirements:
Excellent oral and written communication skills in English/Fluent in English
Able to travel domestically and internationally as required
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What We Do
Fundamentally we exist for one reason: To be the trusted solution for our clients as they strive to build a better working world and improve the human experience.
We are 800+ global experts that bring top-tier expertise to every stage of a project, from creating comprehensive, detailed project plans to eliminating that last punch list item and beyond, into rigorous asset management, reliability, and sustainability activities. We are your choice regardless of your location.
Philosophically and practically, we believe that quality, cost, and schedule can be mutually reinforcing – trade-offs are not necessary. Short-changing the focus on quality usually means problems down the road – problems that can cost money and delay the schedule. But if quality is built in from the start, then both project delivery and operational efficiency can be achieved with a much higher degree of assurance.
When your project requires planned, managed, and documented high quality to exacting global standards. When you need high-performance teams on mission-critical projects. When your project is complex, high-visibility, and carries significant risk. We can help you meet a higher standard.
