CSV Engineer

CSV Engineer - Ireland, North Dublin - 12 Months Initial ContractDo you want to be involved with exciting pharmaceutical projects?When it comes to the development and production of veterinary vaccines, our pharmaceutical client has the largest centre in the industry worldwide and is a Centre of Excellence; employing more than 1000 people. They are looking to add to their team and require a CSV Engineer. Essential Duties and Responsibilities for this role include, but are not limited to, the following:

Manufacturing ProcessesAnalytical and microbiological method validations o Computer system validations SpecificallyDevelop, Review and Execution of project related documentation against current GMP-requirements such as (but not limited to): Planning and Design Qualification (URS, FRS, FAT, SAT) and CommissioningRisk Assessments (e. g. FMEA)Installation-, Operational- and Performance QualificationDocuments for regulatory purposesAssessmentsChange controls, Deviations etc.

Planning and execution of Computerised Systems Validation (CSV) in cooperation with IT and Process AutomationLead and participate in Risk Analysis of equipment, systems and processesIssue Formal Commissioning and Qualification Plans, Protocols and Reports and support different Equipment and Systems owners by providing technical knowledgeApply professional interdisciplinary project teamwork supporting the team with Engineering department, Qualification Department, Production, EHS in questions regarding GMP-compliant solutionsSupport root cause analyses and troubleshooting activities in case of deviations from Qualification/Validation PerspectiveSupport creation, assessment, and completion of change control cases from Qualification/Validation Perspective.

Contact to the overall project leaders in different departments and within the global project team to support project executionDesirable Experience:

Kneat and EVAL software is highly advantageousRequires extensive professional experience in pharmaceutical IndustryExceptional knowledge in the areas of qualification and validation of building, utilities, equipment, manufacturing processes and analytical and microbiological methodsKnowledge in automation and computer system validationProject management knowledge, leadership capabilities with respect to quality topicsExperience with implementation of new pharmaceutical buildings and new line preferredStrong soft skills for the coordination and motivation of interdisciplinary teams in a matrix structureExceptional degree of team spirit, flexibility and robustnessQualification activities not related to the project. If this role is of interest to you, please apply now!