GxP CSV Engineer - Life Sciences Validation Lead

ATS Automation Tooling Systems Inc; Dublin; On-site; EUR 65,000 - 90,000; Full time

Job summary

ATS Automation Tooling Systems Inc is seeking a CSV Engineer (m/f/d) to partner with Orise project teams, performing GxP Computerised Systems CSV activities across multiple projects in the life sciences sector.

Candidates bring a Bachelor’s degree in computer science/engineering or related field (or 5 years’ experience) and at least 3 years CSV experience; strong knowledge of regulatory guidance and change control processes is essential.

Qualifications

• Bachelor’s degree or equivalent in a related field with at least 3 years CSV experience in Life Sciences.
• Detailed knowledge of regulatory guidance documents and standards.

Responsibilities

• Management of client CSV activities and relationships.
• Define CSV strategy with client project teams.
• Preparation/testing of validation protocols and documentation for GxP CS.
• Support operation of systems by executing Periodic Reviews, Change Controls and Audit Trail Reviews.
• Generate CSV documentation and act as Process Champion for internal processes.
• Develop and maintain client site expertise to enhance relationships.
• Develop GxP Lifecycle documents across validation lifecycle for GxP assets.
• Review/approval of all GxP CSV documentation.
• Administration of GAMP lifecycle across concurrent projects.
• Communicate IT/Validation concepts clearly to project teams.
• Be self-starter, organized in a fast-paced environment.
• Interact effectively within customer environment.
• Knowledge of Quality Management System processes e.g., change control, CAPA, deviation.

Skills

Communication skills

Self-motivation

Education

Bachelor’s degree in Computer Science / Computer Engineering / Computer Information Systems

5 years’ relevant experience

Job description

ATS Automation Tooling Systems Inc is seeking a CSV Engineer (m/f/d) to partner with Orise project teams, performing GxP Computerised Systems CSV activities across multiple projects in the life sciences sector.

Candidates bring a Bachelor’s degree in computer science/engineering or related field (or 5 years’ experience) and at least 3 years CSV experience; strong knowledge of regulatory guidance and change control processes is essential.