QA CSV Engineer (12M, Limerick)

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.

Please call Conor Twomey today for further information on 087-0907204 or email: [email protected]

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.