CSV Engineer (m/f/d)

Orise; Dublin; Hybrid; EUR 60,000 - 80,000; Full time

Job summary

Orise is seeking a CSV professional to manage client CSV activities and define validation strategies within project teams. You will prepare and test validation protocols and related documentation for GxP Computerised Systems, supporting Periodic Reviews, Change Controls and Audit Trail Reviews.

The role requires excellent communication, the ability to explain IT/Validation concepts to teams, and a proactive, organized approach.

Qualifications

• Bachelor’s degree in CS/CE or related field or 5 years relevant experience.
• 3+ years CSV experience in Life Sciences.

Responsibilities

• Manage client CSV activities and relationships.
• Define CSV strategy with client project teams.
• Prepare and test validation protocols and documentation for GxP Computerised Systems.
• Support operation of systems by executing Periodic Reviews, Change Controls and Audit Trail Reviews.
• Provide assistance with generation of CSV documentation and act as process champion to improve internal processes.
• Develop and maintain client site expertise to enhance Orise-client relationships.
• Contribute to GxP Computerised Systems lifecycle documents across validation lifecycle for all asset types.
• Review/Approval of GxP Validation Documentation.
• Administer GAMP lifecycle across concurrent projects.
• Any other duties as assigned.

Skills

Communication skills

IT/Validation concepts

Self-starter

Organization

Client interaction

MS Office

Education

BSc in Computer Science/Engineering

Job description

Job Description

Main Responsibilities & Duties

• Management of client CSV activities and relationships
• Working as part of client project teams to define CSV strategy for projects
• Preparation/testing of validation protocols, and all associated documentation for GxP Computerised Systems.
• Support the operation of systems by executing Periodic Reviews, Change Controls and Audit Trail Reviews.
• Provide assistance with the generation of CSV related documentation. Act as Process Champion taking ownership of internal processes to continually develop and improve them as part of the company continual improvement process; be the ‘go-to’ person for the designated process (s)
• Develop and maintain designated client site expertise to enhance the relationship and efficiency between Orise and respective client.
• Working as part of Orise and client teams in the development of GxP Computerised Systems Lifecycle documents across the entire validation lifecycle for all types of GxP assets e.g. Lab, Automation, Business and Equipment systems.
• Review/Approval of all GxP Computerised Systems Validation Documentation.
• Administration of GAMP lifecycle across concurrent projects.
• Any other duties which may be assigned from time to time.

Essential

• Have excellent communication and interpersonal skills, both written and verbal
• Have the ability to communicate IT/Validation concepts/strategies to project teams.
• Be a self-starter and be motivated to provide a solid product quality and customer experience.
• Be organised and adaptable to a fast pace working environment
• Be able to integrate and interact well within the customer environment.
• Have excellent Microsoft Office user level skills

Desirable

• Strong knowledge of Quality Management System Processes i.e., change control, CAPA, deviation

Education & Experience

• A Bachelor’s degree in Computer Science, Computer Engineering, Computer Information Systems, or a related field (or 5 years’ relevant experience).
• A minimum of 3 years CSV experience in the Life Sciences sector
• Detailed knowledge of regulatory guidance documents and standards