CSV Engineer

Cork

3 months ago

Applications closed

Cognizant is a world leader in delivering digital transformation solutions to Life Sciences. Through our knowledge and expertise in Automation, MES & Digital, we deliver stable manufacturing systems that are optimized to improve operational efficiencies, whilst maintaining compliance.

Our specialist engineering teams have the aptitude to deliver and support Pharma 4.0 architectures and solutions covering all IT, OT and IoT applications, infrastructures and services.

Operating across 5 continents and with over 300.000 skilled employees, Cognizant partners with the leading Life Sciences companies globally to provide performance improvements, reduced costs and improve time to market. We are your single end to end partner for consultancy, design implementation, optimization and support for all applications in the Pharmaceutical and Biotechnology Manufacturing stack.

We’re looking for dedicated, innovative and driven talent to join our expanding team.

About the role:

We are currently looking to hire an CSV Validation Engineer to join our projects team in Cork, supporting multiple projects with the worlds leading Pharmaceutical and Biotech companies.

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.
3-5 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

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