On-site Pharma CSV Engineer: Validation & Compliance

Project Delivery Partners Pte Ltd; Limerick; Hybrid; EUR 65,000 - 90,000; Full time

Job summary

Project Delivery Partners Pte Ltd in Limerick is seeking a Computer System Validation (CSV) Engineer to ensure computerized systems in pharmaceutical environments are validated and compliant with industry regulations.

You will author and execute IQ/OQ/PQ validation protocols, review URS and design documents, manage change control, and support cross‑functional audits for manufacturing, laboratory and business systems.

Qualifications

• Degree in Engineering, Computer Science, Life Sciences, or related discipline.
• Demonstrated CSV experience in pharmaceutical or regulated industries.
• Strong knowledge of regulations, quality standards, and best practices for computer systems validation (GxP, GAMP 5, FDA 21 CFR Part 11, Annex 11).
• Experience developing and executing validation protocols (IQ/OQ/PQ) for manufacturing, lab, or business systems.
• Understanding of SDLC concepts, test methodologies, and change management in a regulated environment.
• Excellent analytical, documentation, and problem-solving skills.
• Effective communication and interpersonal skills; able to work independently and collaboratively.
• Attention to detail and commitment to compliance and quality.

Responsibilities

• Plan, author, execute, and maintain validation protocols and documentation for new and existing computer systems (including manufacturing, laboratory, and business systems).
• Ensure all CSV activities comply with relevant regulatory standards (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5, GMP).
• Collaborate with IT, QA, Engineering, and Operations teams to identify, scope, and manage CSV projects.
• Review and approve lifecycle documents, including User Requirements Specifications (URS), Functional/Design Specifications, Risk Assessments, IQ/OQ/PQ protocols, and validation summary reports.
• Participate in system implementation projects, supporting system development, testing, and deployment activities.
• Manage changes to validated computer systems through formal change control processes.
• Conduct periodic reviews and re-validation activities as required.
• Support investigations, deviations, CAPAs, and audits relating to computer systems.
• Provide training and guidance to cross-functional teams on CSV requirements and practices.
• Keep up to date with regulatory trends and technology changes impacting CSV.

Skills

CSV experience

GxP

GAMP 5

FDA Part 11

Annex 11

SDLC concepts

Test methodologies

Change management

Documentation

Regulatory compliance

Interpersonal skills

Education

Engineering degree

Computer Science degree

Life Sciences degree

Tools

MES

LIMS

Job description

Project Delivery Partners Pte Ltd in Limerick is seeking a Computer System Validation (CSV) Engineer to ensure computerized systems in pharmaceutical environments are validated and compliant with industry regulations.

You will author and execute IQ/OQ/PQ validation protocols, review URS and design documents, manage change control, and support cross‑functional audits for manufacturing, laboratory and business systems.