Senior CSV Engineer (m/f/d)

Orise; Blanchardstown; On-site; EUR 65,000 - 95,000; Full time

Job summary

Orise is seeking a CSV Engineer to collaborate with project teams on GxP Computerised Systems CSV activities across multiple projects. The role focuses on defining CSV strategy with clients and preparing validation protocols and associated documentation.

The successful candidate will manage CSV activities, support system operations through periodic reviews and change controls, and contribute to continual improvement of processes while maintaining strong client relationships.

Qualifications

• Bachelor’s degree in Computer Science or related field or 5 years’ relevant experience.
• Minimum 3 years CSV experience in the Life Sciences sector.
• Detailed knowledge of regulatory guidance documents and standards.

Responsibilities

• Manage CSV activities and client relationships.
• Define CSV strategy with client project teams.
• Prepare and test validation protocols and documentation for GxP CS.
• Support operation of systems with Periodic Reviews, Change Controls and Audit Trail Reviews.
• Assist with generation of CSV related documentation.
• Act as Process Champion to improve internal processes.

Skills

CSV compliance

Client communication

Project teamwork

Self-starter

Education

BSc in CS/CE

Regulatory knowledge

Job description

The CSV Engineer will operate with the Orise project teams in performing GxP Computerised Systems CSV activities for several projects.

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.
• 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.
• 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

ATS is in compliance with the Accessibility for Ontarians with Disability Act (AODA), 2005 and will, upon request, assist those who may require specific accommodations due to a personal disability. We would ask that those who require assistance to notify our offices as soon as possible if accommodation is necessary.

The ATS applicant tracking system may utilize AI software with pre defined, rule based filters to organize and manage application materials. Rule based filters operate solely on fixed criteria and do not perform autonomous evaluation or generate independent recommendations. All hiring decisions continue to involve human review and judgment.