CSV Specialist: GMP Computerised Systems Validation

Sharp Services, LLC; Rhymney; Hybrid; GBP 48,000 - 75,000; Full time

Job summary

Sharp Services, LLC seeks a Computerised Systems Validation Specialist to oversee CSV status of GMP IT systems at the Rhymney site, with onsite or hybrid working and travel to European sites. You will maintain validation master plans, prepare documentation, and coordinate validation activities with IT, Operations, Supply Chain and QA.

The role requires GMP knowledge, experience in pharma environments, and the ability to travel regularly to Sharp sites in Belgium and the Netherlands.

Qualifications

• Bachelor's or master's degree in information technology or related field preferred.
• Experience in a pharmaceutical manufacturing or production environment.
• Experience planning, delivering and overseeing computerised systems validation.
• Working knowledge of GMP requirements and related regulations.
• Experience with quality management systems, controlled procedures and training processes.
• Willingness to travel regularly to Sharp sites in Belgium and the Netherlands.

Responsibilities

• Maintain oversight of IT systems and their CSV status across sites.
• Prepare validation documentation including risk/regulatory assessments, test protocols and validation reports.
• Plan, coordinate and deliver validation activities with IT, Operations and Quality teams.
• Document validation activities and results accurately and completely.
• Support internal audits and act as CSV SME during external audits and inspections.

Skills

CSV validation expertise

Analytical thinking

Organisational skills

Problem solving

Independent & team work

Education

Bachelor's or Master's in IT

Tools

Microsoft Office

Job description

Sharp Services, LLC seeks a Computerised Systems Validation Specialist to oversee CSV status of GMP IT systems at the Rhymney site, with onsite or hybrid working and travel to European sites. You will maintain validation master plans, prepare documentation, and coordinate validation activities with IT, Operations, Supply Chain and QA.

The role requires GMP knowledge, experience in pharma environments, and the ability to travel regularly to Sharp sites in Belgium and the Netherlands.