Senior CSV Engineer (m/f/d)

Orise; Blanchardstown; On-site; EUR 55,000 - 85,000; Full time

Job summary

Orise is seeking a CSV Engineer to collaborate with project teams on GxP Computerised Systems CSV activities across multiple projects in Ireland. You will manage client CSV activities, define strategies with teams, and prepare validation protocols with associated documentation.

You will support periodic reviews, change controls and audit trail reviews, producing CSV documentation and acting as a process champion to continuously improve internal processes and client interactions.

Qualifications

• Bachelor’s degree in a relevant field or 5 years of CSV experience.
• A minimum of 3 years CSV experience in the Life Sciences sector.
• Detailed knowledge of regulatory guidance documents and standards.

Responsibilities

• Manage CSV activities and client relationships.
• Work with project teams to define CSV strategy for projects.
• Prepare and test validation protocols and related documentation for GxP CS.
• Support Periodic Reviews, Change Controls and Audit Trail Reviews.
• Assist in generating CSV-related documentation.
• Act as Process Champion to improve internal processes.
• Develop and maintain client site expertise to enhance Orise relationships.
• Contribute to GxP CS lifecycle documents across validation lifecycle for various assets.
• Review/approve all GxP CS Validation Documentation.
• Administer GAMP lifecycle across concurrent projects.
• Perform other duties as assigned.
• Communicate IT/Validation concepts effectively to teams.
• Be organized and adapt to fast-paced environments.
• Interact well within customer environments.
• Strong knowledge of Quality Management System processes (change control, CAPA, deviation).

Skills

GxP CS

Client relationship management

Excellent communication

Self-starter

Education

Bachelor’s degree in Computer Science/Computer Engineering/Computer Information Systems or related field

5 years relevant CSV experience

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.