Senior CSV Engineer

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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