Job description

I am currently recruiting a CSV engineer to join a leading Cork based pharmaceutical on a contract basis. This is initially a 12-18 month contract but will be moving into a permanent position, if that is what the candidate wants. There is a very attractive hourly rate on offer, and this is not an opportunity to be missed.

Responsibilities include but are not limited to:

• Automation Change (IRIS) Review and Approval
• Experience with Emerson Delta other DCS System PLC SCADA
• Develop and complete continuous improvements as part of the validation team- Co-ordination of changes to ensure timely delivery.
• CSV Deliverables including 21CFR11 Assessments Annex 11 Assessments Business Criticality Assessments GAMP Assessments
• Review and Approval of Automation Designs
• Installation and Operation Qualification (IOQ) Protocol Generation Execution and Reporting for DeltaV (PAS) PLCs Honeywell (QBAS/NQBAS) MES
• Test specification pre-approval review and post approval prior to progression to IOQ- Change Control Impact Assessments
• Maintenance Review and Approval of site Quality documentation e.g. SLIA CLIA System

Essential Criteria

• BS in Engineering, Computer Science, Science or other technical degree.
• 2-5 years’ experience of working in a pharmaceutical API manufacturing operation is desirable.
• Experience with Labware any LIMS essential
• Candidates will be required to have excellent communication/interpersonal skills with the ability to work on their own initiative.
• iRCAS Communication Skills
• Must be available to work minimum 3 days per week onsite.