QA CSV Engineer (12M, Limerick)

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

QA COMPUTER SYSTEMS VALIDATION ENGINEER required by CareerWise Recruitment for our multinational Life Sciences client in Limerick...this is a 12 month contract role and is based on-site (4 days on-site & 1 day remote).

The QA COMPUTER SYSTEMS VALIDATION ENGINEER will have validated a Scada systems (e.g DeltaV, FactoryTalk) or an asset management system (Maximo, BMRAM).

NOTE: No sponsorship is provided for this role so applicants need to already have Irish / EU citizenship OR the relevant Stamp / Visa in place.

Responsibilities

• Prepares/reviews validation documentation related to projects/change controls.
• Manages change controls and other compliance related tasks e.g. non-conformances.
• Participates in the review of current and future CSV procedures and polices
• Analyzes the results of testing and determines the acceptability of results against predetermined criteria.
• Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
• Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.
• Coordinates with other departments or outside contractors/vendors to complete validation tasks.
• Participates in regulatory audits and communicates company’s computer validation policies.
• Assesses company’s computer systems and identifies any potential Part 11 or Annex 11 gaps.
• Manages projects and prepares status reports using Microsoft project and other communication tools.

Education and Experience

• Requires BS/BA in Engineering, Chemistry, or Life Sciences.
• 5+ years of related experience within the fields of Automation and Computer systems and IT Infrastructure Qualification/validation; will substitute relevant experience for education.
• Experience in a GMP environment essential.
• Experience with validation of any of the following highly desirable; DeltaV, Maximo, etc.