CSV QA Engineer — GMP Validation in Life Sciences

CareerWise Recruitment; Limerick; On-site; EUR 60,000 - 80,000; Full time

Job summary

CareerWise Recruitment seeks a QA Computer Systems Validation Engineer in Limerick for a 12-month on-site contract (4 days on-site, 1 day remote). The role focuses on validating CSV processes for DeltaV/FactoryTalk systems and asset management platforms, ensuring compliance with Part 11/Annex 11 requirements.

Requires 5+ years in automation validation within GMP settings. Irish/EU citizenship or valid Stamp/Visa required; sponsorship is not provided.

Qualifications

• Requires BS/BA in Engineering, Chemistry, or Life Sciences.
• 5+ years of related experience in Automation and Computer systems qualification/validation.
• Experience in a GMP environment essential.
• Experience with validation of DeltaV, Maximo, etc. would be highly desirable.

Responsibilities

• Prepares/reviews validation documentation related to projects/change controls.
• Manages change controls and other compliance-related tasks (non-conformances).
• Reviews current and future CSV procedures and policies.
• Analyzes testing results to determine acceptance.
• Investigates issues and suggests improvements.
• Identifies requirements for compliant computerized operations and advises on procedures and documentation.

Skills

QA Validation

GMP experience

Regulatory audits

Change controls

Project management

Education

BS/BA in Engineering, Chemistry or Life Sciences

Tools

DeltaV

FactoryTalk

Maximo

BMRAM

Job description

CareerWise Recruitment seeks a QA Computer Systems Validation Engineer in Limerick for a 12-month on-site contract (4 days on-site, 1 day remote). The role focuses on validating CSV processes for DeltaV/FactoryTalk systems and asset management platforms, ensuring compliance with Part 11/Annex 11 requirements.

Requires 5+ years in automation validation within GMP settings. Irish/EU citizenship or valid Stamp/Visa required; sponsorship is not provided.