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Headcount Solutions requires a Computer Systems MES Validation Engineer for a clients biopharmaceutical manufacturing facility.
The principal responsibilities will include IQ, OQ, PQ protocol generation and execution, exception management, report generation, business flow mapping, the execution of qualification testing and the compilation of the subsequent reports.
• Work within a team of MES validation engineers
• Participation in business flow mapping
• Review and approval of local design documentation
• Generation and execution of qualification protocols
• Exception management
• Generation of qualification summary reports
• Generation of other life cycle documents, such as RTMs
• Qualification of additional tools supporting MES setup, such as bulk master data upload tool.
Requirements:
• Degree qualification in relevant engineering or science-based discipline
• Minimum of 5 years experience of validation activity in a project environment within the pharmaceutical or biotech industries
• Exposure to DeltaV, OSI PI and SAP is an advantage
• Exposure to PAS-X application is an advantage.
• Strong experience in qualification of various automation and computerised systems
• Experience of working as part of a multidisciplinary team, and should be results focused with excellent communication and interpersonal skills
For further information please contact Michael McQuade @ 086-0435195 / 01-6905040 or submit cv in strictest confidence to jobs@headcount.ie
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