Duration:
12 Months
Working hours:
39 hours per week
Onsite requirements:
Onsite
Engagement Type:
LTD Company Contractor
Hourly rate:
***** EUR per hour
Legal Right to Work:
You must have the legal right to work in Ireland.
No sponsorship is available for this role.
Atrium Global is supporting a client within the pharmaceutical industry to appoint a highly skilled CSV Engineer.
This position plays a key role in ensuring regulated systems, laboratory software, analytical instruments and manufacturing technologies meet full compliance across the business.
Job Overview
You will take ownership of end-to-end computer system validation activities, working across Quality, IT, Laboratory and Manufacturing teams.
This role involves developing validation protocols, managing qualification of analytical instruments, supporting audits and ensuring that all systems meet the highest standards of data integrity and regulatory compliance.
It is an excellent opportunity for an experienced CSV specialist with strong exposure to QC laboratories, PAT, enterprise laboratory systems and paperless validation tools.
Responsibilities
Develop and execute IQ, OQ and PQ protocols for computer systems, laboratory instruments and software applications.
Partner with IT, QA and Operations to maintain compliance with regulatory guidelines and internal quality systems.
Conduct system-level risk assessments and impact analyses.
Create and manage validation documentation including plans, test scripts, traceability matrices and summary reports.
Perform periodic reviews to ensure sustained compliance.
Support change control by assessing validation impact and defining required activities.
Provide subject matter expertise on CSV principles, regulations and best practice.
Monitor updates to regulatory expectations and industry trends.
Work with vendors to ensure external systems meet validation standards.
Support audits and inspections by preparing and presenting CSV evidence.
Lead qualification of analytical instruments including Cell Viability Analysers, Liquid Handlers and other QC laboratory technologies.
Requirements
Bachelor's degree in Computer Science, Engineering or a related field.
Strong working knowledge of FDA 21 CFR Part 11, EU Annex 11 and GAMP 5.
5+ years of CSV experience in a regulated pharmaceutical or biotechnology environment.
Understanding of risk-based validation methodologies.
Proven experience creating and executing validation protocols with high-quality documentation.
Strong analytical and problem-solving skills with excellent attention to detail.
Confident communication skills with the ability to work across multiple functions.
Ability to manage several projects simultaneously and independently.
Understanding of SDLC, change control and data integrity principles.
Experience supporting sterile drug product manufacturing environments and associated laboratory and IT systems.
Must-Haves
Extensive experience delivering CSV from requirements through release of analytical instruments used in QC laboratories or PAT-based manufacturing operations.
Strong background validating server or database-based laboratory software, middleware and enterprise applications such as LIMS, Empower and NuGenesis.
Demonstrated experience completing Electronic Record Electronic Signatures (ERES) assessments and Data Integrity Risk Assessments.
Hands-on experience using paperless validation and test management tools including ValGenesis, Kneat and ALM.
Seniority level
Mid-Senior level
Employment type
Contract
Job function
Pharmaceutical Manufacturing, Biotechnology Research, and Manufacturing
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